Search results for: sleep study

Authors: Yasmeen Jamal Alabdallat, Almutazballlah Bassam Qablan, Hamza Al-Salhi, Salameh Alarood, Ibraheem Alkhawaldeh, Obada Abunar, Adam Abdallah

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Obstructive sleep apnea (OSA) is a disorder caused by the repeated collapse of the upper airway during sleep. It is the most common cause of sleep-related breathing disorder, as OSA can cause loud snoring, daytime fatigue, or more severe problems such as high blood pressure, cardiovascular disease, coronary artery disease, insulin-resistant diabetes, and depression. The hypoglossal nerve stimulator (HNS) is an implantable medical device that reduces the occurrence of obstructive sleep apnea by electrically stimulating the hypoglossal nerve in rhythm with the patient's breathing, causing the tongue to move. This stimulation helps keep the patient's airways clear while they sleep. This systematic review and meta-analysis aimed to assess the clinical outcome of hypoglossal nerve stimulation as a treatment of obstructive sleep apnea. A computer literature search of PubMed, Scopus, Web of Science, and Cochrane Central Register of Controlled Trials was conducted from inception until August 2022. Studies assessing the following clinical outcomes (Apnea-Hypopnea Index (AHI), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), Oxygen Desaturation Indices (ODI), (Oxygen Saturation (SaO2)) were pooled in the meta-analysis using Review Manager Software. We assessed the quality of studies according to the Cochrane risk-of-bias tool for randomized trials (RoB2), Risk of Bias In Non-randomized Studies - of Interventions (ROBINS-I), and a modified version of NOS for the non-comparative cohort studies.13 Studies (Six Clinical Trials and Seven prospective cohort studies) with a total of 817 patients were included in the meta-analysis. The results of AHI were reported in 11 studies examining OSA 696 patients. We found that there was a significant improvement in the AHI after 12 months of HNS (MD = 18.2 with 95% CI, (16.7 to 19.7; I2 = 0%); P < 0.00001). Further, 12 studies reported the results of ESS after 12 months of intervention with a significant improvement in the range of sleepiness among the examined 757 OSA patients (MD = 5.3 with 95% CI, (4.75 to 5.86; I2 = 65%); P < 0.0001). Moreover, nine studies involving 699 participants reported the results of FOSQ after 12 months of HNS with a significant reported improvement (MD = -3.09 with 95% CI, (-3.41 to 2.77; I2 = 0%); P < 0.00001). In addition, ten studies reported the results of ODI with a significant improvement after 12 months of HNS among the 817 examined patients (MD = 14.8 with 95% CI, (13.25 to 16.32; I2 = 0%); P < 000001). The Hypoglossal Nerve Stimulation showed a significant positive impact on obstructive sleep apnea patients after 12 months of therapy in terms of apnea-hypopnea index, oxygen desaturation indices, manifestations of the behavioral morbidity associated with obstructive sleep apnea, and functional status resulting from sleepiness.

Keywords: apnea, meta-analysis, hypoglossal, stimulation

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Authors: Seyed Mahdi Jameii, Arash Nikdel, Seyed Mohsen Jameii

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Energy efficiency is an important issue in the field of Wireless Sensor Networks (WSNs). So, minimizing the energy consumption in this kind of networks should be an essential consideration. Sleep/wake scheduling mechanism is an efficient approach to handling this issue. In this paper, we propose a Genetic Algorithm-based Sleep-Wake up Area Coverage protocol called GA-SWAC. The proposed protocol puts the minimum of nodes in active mode and adjusts the sensing radius of each active node to decrease the energy consumption while maintaining the network’s coverage. The proposed protocol is simulated. The results demonstrate the efficiency of the proposed protocol in terms of coverage ratio, number of active nodes and energy consumption.

Keywords: wireless sensor networks, genetic algorithm, coverage, connectivity

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Authors: Ke Qiu, Minzi Mao, Jianjun Ren, Yu Zhao

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Although much has been done to investigate the influence of obstructive sleep apnea (OSA) on cognitive function, little attention has been paid to the role which gender differences play in this association. In the present study, we aim to explore the gender-specific association between OSA and cognitive impairment. Participants from UK biobank who have completed at least one of the five baseline cognitive tests (visuospatial memory, prospective memory, fluid intelligence, short numeric memory and reaction time) were included and were further categorized into three groups: (1) OSA, (2) self-reported snoring but without OSA, and (3) healthy controls (without OSA or snoring). Multivariable regression analysis was performed to examine the associations among snoring, OSA and performance of each of the five cognitive domains. A total of 267,889 participants (47% male, mean age: 57 years old) were included in our study. In the multivariable regression analysis, female participants in the OSA group had a higher risk of having poor prospective memory (OR: 1.24, 95% CI: 1.02～1.50, p = 0.03). Meanwhile, among female participants, OSA were inversely associated with the performances of fluid intelligence (β: -0.29, 95% CI: -0.46～-0.13, p < 0.001) and short-numeric memory (β: -0.14, 95% CI: -0.35～0.08, p = 0.02). In contrast, among male participants, no significant association was observed between OSA and impairment of the five cognitive domains. Overall, OSA was significantly associated with cognitive impairment in female participants rather than in male participants, indicating that more special attention and timely interventions should be given to female OSA patients to prevent further cognitive impairment.

Keywords: obstructive sleep apnea (OSA), cognitive impairment, gender-specific association, UK biobank

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Authors: Santanu Chattopadhyay, Gautam Sarkar, Arabinda Das

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This paper presents wavelet based classification of various heart diseases. Electrocardiogram signals of different heart patients have been studied. Statistical natures of electrocardiogram signals for different heart diseases have been compared with the statistical nature of electrocardiograms for normal persons. Under this study four different heart diseases have been considered as follows: Myocardial Ischemia (MI), Congestive Heart Failure (CHF), Arrhythmia and Sleep Apnea. Statistical nature of electrocardiograms for each case has been considered in terms of kurtosis values of two types of wavelet coefficients: approximate and detail. Nine wavelet decomposition levels have been considered in each case. Kurtosis corresponding to both approximate and detail coefficients has been considered for decomposition level one to decomposition level nine. Based on significant difference, few decomposition levels have been chosen and then used for classification.

Keywords: arrhythmia, congestive heart failure, discrete wavelet transform, electrocardiogram, myocardial ischemia, sleep apnea

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Authors: Abdullah S. Alghamdi, Khaled Alghamdi, Richard O. Jenkins, Parvez I. Haris

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Background: Quantity and quality of sleep have been reported to be significant risk factors for obesity and development of metabolic disorders such as type 2 diabetes mellitus (T2DM). The relationship between diabetes and sleep quantity was reported to be U-shaped, which means increased or decreased sleeping hours can increase the risk of diabetes. The plasma glucagon levels were found to continuously decrease during night-time sleep in healthy individuals, independently of blood glucose and insulin levels. The disturbance of the circadian rhythm is also important and has been linked with an increased the chance of diabetes incidence. There is a lack of research on sleep patterns on Saudis with T2DM and how this is affected by Ramadan fasting. Aim: To assess the sleeping patterns of Saudis with T2DM (before, during, and after Ramadan), using two different techniques and relate this to their HbA1c levels. Method: This study recruited 82 Saudi with T2DM, who chose to fast during Ramadan, from the Endocrine and Diabetic Centre of Al Iman General Hospital, Riyadh, Saudi Arabia. Ethical approvals for the study were obtained from De Montfort University and Saudi Ministry of Health. Their sleeping patterns were assessed by a self-administered questionnaire (before, during, and after Ramadan). The assessment included the daily total sleeping hours (DTSH), and total night-time sleeping hours (TNTSH) of the participants. In addition, sleeping patterns of 36 patients, randomly selected from the 82 participants, were further tracked during and after Ramadan by using Fitbit Flex 2™ accelerometer. Blood samples were collected in each period for measuring HbA1c. Results: Questionnaire analysis revealed that the sleeping patterns significantly changed between the periods, with shorter hours during Ramadan (P < 0.001 for DTSH, and P < 0.001 for TNTSH). These findings were confirmed by the Fitbit data, which also indicated significant shorter sleeping hours for the DTSH, and the TNTSH during Ramadan (P < 0.001 and P < 0.001, respectively). Although there were no significant correlations between the questionnaire and Fitbit data, the TNTSH were shorter among the participants in all periods by both techniques. The mean HbA1c significantly varied between periods, with lowest level during Ramadan. Although the statistical tests did not show significant variances in the mean HbA1c between the groups of participants regarding their hours of sleeping, the lowest mean HbA1c was observed in the group of participants who slept for 6-8 hours and had longer night-time sleeping hours. Conclusion: A short sleep duration, and absence of night-time sleep were significantly observed among the majority of the study population during Ramadan, which could suppress the full benefits of Ramadan fasting for diabetic patients. This study showed that there is a good agreement between the findings of the questionnaire and the Fitbit device for evaluating sleeping patterns in a Saudi population. A larger study is needed in the future to investigate the impact of Ramadan fasting on sleep quality and quantity and its relationship with health and disease.

Keywords: Diabetes, Fasting, Fitbit, HbA1c, IPAQ, Ramadan, Sleep

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Authors: Parastoo Vasli

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In today's society, more and more people work during ‘non-standard’ working hours, including shift and night work, which are perceived danger factors for health, safety, and social prosperity. Appropriate preventive and protective measures are needed to reduce side effects and ensure that the worker can adapt sufficiently. Of the many health effects associated with shift work, sleep disorders are the most widely recognized. The most troubling acute symptoms are difficulty falling asleep, short sleep, and drowsiness during working hours that last for days on end. The outcomes checked on plainly exhibit that shift work is related to expanded mental, social, and physiological drowsiness. Apparently, the effects are due to circadian and hemostatic compounds (sleep loss). Drowsiness is especially evident during night shifts and may lead to drowsiness in real workplace accidents. In some occupations, this is clearly a risk that could endanger human lives and has enormous financial outcomes. These dangers clearly affect a large number of people and should be of great importance to society. In particular, safety on night shifts is consistently reduced.

Keywords: shift work, night work, safety, health, drowsiness

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Authors: M. Trousselard, D. Steiler, C. Drogou, P. van-Beers, G. Lamour, S. N. Crosnier, O. Bouilland, P. Dubost, M. Chennaoui, D. Léger

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According to published data, undersea navigation for long periods (nuclear-powered ballistic missile submarine, SSBN) constitutes an extreme environment in which crews are subjected to multiple stresses, including the absence of natural light, illuminance below 1,000 lux, and watch schedules that do not respect natural chronobiological rhythms, for a period of 60-80 days. These stresses seem clearly detrimental to the submariners’ sleep, with consequences for their affective (seasonal affective disorder-like) and cognitive functioning. In the long term, there are abundant publications regarding the consequences of sleep disruption for the occurrence of organic cardiovascular, metabolic, immunological or malignant diseases. It seems essential to propose countermeasures for the duration of the patrol in order to reduce the negative physiological effects on the sleep and mood of submariners. Light therapy, the preferred treatment for dysfunctions of the internal biological clock and the resulting seasonal depression, cannot be used without data to assist knowledge of submariners’ chronobiology (melatonin secretion curve) during patrols, given the unusual characteristics of their working environment. These data are not available in the literature. The aim of this project was to assess, in the course of two studies, the benefits of two environmental techniques for managing chronobiological stress: techniques for optimizing potential (TOP; study 1)3, an existing programme to help in the psychophysiological regulation of stress and sleep in the armed forces, and dawn and dusk simulators (DDS, study 2). For each experiment, psychological, physiological (sleep) or biological (melatonin secretion) data were collected on D20 and D50 of patrol. In the first experiment, we studied sleep and depressive distress in 19 submariners in an operational setting on board an SSBM during a first patrol, and assessed the impact of TOP on the quality of sleep and depressive distress in these same submariners over the course of a second patrol. The submariners were trained in TOP between the two patrols for a 2-month period, at a rate of 1 h of training per week, and assigned daily informal exercises. Results show moderate disruptions in sleep pattern and duration associated with the intensity of depressive distress. The use of TOP during the following patrol improved sleep and depressive mood only in submariners who regularly practiced the techniques. In light of these limited benefits, we assessed, in a second experiment, the benefits of DDS on chronobiology (daily secretion of melatonin) and depressive distress. Ninety submariners were randomly allocated to two groups, group 1 using DDS daily, and group 2 constituting the control group. Although the placebo effect was not controlled, results showed a beneficial effect on chronobiology and depressive mood for submariners with a morning chronotype. Conclusions: These findings demonstrate the difficulty of practicing the tools of psychophysiological management in real life. They raise the question of the subjects’ autonomy with respect to using aids that involve regular practice. It seems important to study autonomy in future studies, as a cognitive resource resulting from the interaction between internal positive resources and “coping” resources, to gain a better understanding of compliance problems.

Keywords: chronobiology, light therapy, seasonal affective disorder, sleep, stress, stress management, submarine

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Authors: Filip Franciszek Karuga, Szymon Turkiewicz, Marta Ditmer, Marcin Sochal, Piotr Białasiewicz, Agata Gabryelska

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Circadian rhythm, an internal coordinator of physiological processes is composed of a set of semi-autonomous clocks. Clocks are regulated through the expression of circadian clock genes which form feedback loops, creating an oscillator. The primary loop consists of activators: CLOCK, BMAL1 and repressors: CRY, PER. CLOCK can be substituted by the Neuronal PAS Domain Protein 2 (NPAS2). Orphan nuclear receptor (REV-ERB-α) is a component of the secondary major loop, modulating the expression of BMAL1. Circadian clocks might be disrupted by the obstructive sleep apnea (OSA), which has also been associated with type II diabetes mellitus (DM2). Interestingly, studies suggest that dysregulation of NPAS2 and REV-ERB-α might contribute to the pathophysiology of DM2 as well. The goal of our study was to examine the role of NPAS2 and REV-ERB-α in DM2 in OSA patients. After examination of the clinical data, all participants underwent polysomnography (PSG) to assess their apnea-hypopnea index (AHI). Based on the acquired data participants were assigned to one of 3 groups: OSA (AHI>30, no DM2; n=17 for NPAS2 and 34 for REV-ERB-α), DM2 (AHI>30 + DM2; n=7 for NPAS2 and 15 for REV-ERB-α) and control group (AHI<5, no DM2; n=16 for NPAS2 and 31 for REV-ERB-α). ELISA immunoassay was performed to assess the serum protein level of REV-ERB-α and NPAS2. The only statistically significant difference between groups was observed in NPAS2 protein level (p=0.037). Post-hoc analysis showed significant differences between the OSA and the control group (p=0.017). AHI and NPAS2 level was significantly correlated (r=-0.478, p=0.002) in all groups. A significant correlation was observed between the REV-ERB-α level and sleep efficiency (r=0.617, p=0.005) as well as sleep maintenance efficiency (r=0.645, p=0.003) in the OSA group. We conclude, that NPAS2 is associated with OSA severity and might contribute to metabolic sequelae of this disease. REV-ERB-α on the other hand can influence sleep continuity and efficiency.

Keywords: OSA, diabetes mellitus, endocrinology, chronobiology

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Authors: Amel Fayed, Shaden AlSubaih, Nouf Al-Qahtani, Asmaa Gosty, Asma Aljuhaimi

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Introduction: Sleep difficulties are vastly predominant among adults and affect different aspects of their life. Many literatures found out that females are more liable to suffer from sleeping problems. College students are typical example of people dealing with daily pressure and stress to fulfill the daily tasks and responsibilities. In addition to their ultimate goal of achieving excellent academic records which require their full concentration and effort. Consequently, many of them start complaining of sleep deprivations which can undesirably affect their academic achievements. This study was aiming to investigate how prevalent is sleeping disorders among different colleges in the university and its relation their academic achievements. Methods: A cross-sectional study of female university students at Princess Norah Bint Abdulrahman University using self-administered questionnaire was conducted. Insomnia Severity Index (ISI) was used to assess different grades of insomnia. Students were requested to answer the questions evaluating their sleeping habits over the last two weeks. Participants reported their latest Grade Point Average (GPA). According to ISI, insomnia severity is reported as ‘No clinically significant’, ‘Subthreshold ‘,’ Clinical moderate insomnia’ and ‘Clinical severe’. Results: In the current study, 228 students participated; 172(75.4%) from medical colleges and 56 (24.6%) from non-medical colleges. About 80% of them claimed to have never taken any medications to help them sleep while only three students confirmed their regular use of sleep-inducing medications. About 16% of the students drink milk or other hot drinks to help them fall asleep. None of the students was suspected of having obstructive sleep apnea or apparent psychiatric disorder. According to ISI, 182 (79.8%) students suffered from subthreshold insomnia, 37 (16.2%) had clinical insomnia (moderate severity) and 9 (3.9%) of students had sleeping problems of non-clinically significance level. However, none of students was found to have severe clinical insomnia. Clinical moderate insomnia was reported in 15.1% of medical students and 19.6% of non-medical students. Moreover, about 82% of medical students suffered from subthreshold insomnia compared to 73.2% of non-medical students. This difference was not statistically significant (P=0.24). About 63% of medical students and 48% of non-medical students believed that high percentage of their colleagues are suffering from insomnias (p-value 0.08) The association between GPA and insomnia revealed that; 19.5% of low GPA group compared to 9.3% of high GPA group had clinical moderate insomnia. This association was not statistically significant (p=0.15). The correlation between the GPA and the ISI score was negative but not conclusive (r=-0.08, p-value = 0.29). More than 92% of all students agreed that sleeping problems affect their academic achievement to varying degrees. Conclusion: our results suggest that insomnia is commonly prevalent among female university students and might affect the students’ achievement. This study provides preliminary data about the quality of sleep among medical and non-medical university students which may be used to promote the healthy sleeping habits among female students.

Keywords: academic achievement, females, insomnia, university student

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Authors: Nemeh Ahmad Al-Akour, Ibrahem Alfaouri

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Objective: To examine the level of maternal awareness of SIDS and its prevention amongst Jordanian mothers in the north of Jordan, as well as to determine their SIDS-related infant care practices. Design: A cross-sectional design. Setting: The study was conducted in maternal out-patients clinics of two teaching hospitals and three maternal and child health clinic in three major health care centers in Northern Jordan. Participants: A total of 356 mothers of infants attending the maternal and child health clinics were included in this study. Measurements and findings: A self-administered questionnaire was used for collecting data study. In this study, 64%of mothers didn’t hear about SIDS, while only 7% of mothers were able to identify factors risk-reducing recommendations. Avoidance of prone sleeping was the most frequently identified recommendation (5%). There were 67.7% of mothers who put their infant in a lateral position to sleep, 61% used soft mattress surface for their babies sleep and 25.8% who shared a bed with their babies. Employed mother, mothers of higher age, and mothers living within a nuclear family were the only factors associated with maternal awareness of SIDS. Friends were the highest a source of knowledge of SIDS for mothers (44.7%). Key conclusions: There was a low level of awareness of SIDS and its associated risk factor among the mothers in Jordan. The mothers' misconception about smoking and sleeping position for their infants requires further efforts. Implications for practice: To ensure raising awareness of infant care practice regarding SIDS, a national educational intervention on SIDS risk reduction strategies and recommendations is necessary for maintaining a low rate of SIDS in the population.

Keywords: bed sharing, infant care, Jordan, sleep position, sudden infant death

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Authors: Suleman Maliha, Suleman Sidra

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Obstructive sleep apnea (OSA) is a sleep disorder that can result in behavioral and psychomotor impairments in children. The classical treatment modalities for OSA have been continuous positive airway pressure and adenotonsillectomy. However, orthodontic intervention through rapid maxillary expansion (RME) has also been commonly used to manage skeletal transverse maxillary discrepancies. Aim and objectives: The aim of this study is to determine the efficacy of rapid maxillary expansion in paediatric patients with obstructive sleep apnea by assessing pre and post-treatment mean apnea-hypopnea index (AHI) and oxygen saturations. Methodology: Literature was identified through a rigorous search of the Embase, Pubmed, and CINAHL databases. Articles published from 2012 onwards were selected. The inclusion criteria consisted of patients aged 18 years and under with no systemic disease, adenotonsillar surgery, or hypertrophy who are undergoing RME with AHI measurements before and after treatment. In total, six suitable papers were identified. Results: Three studies assessed patients pre and post-RME at 12 months. The first study consisted of 15 patients with an average age of 7.5 years. Following treatment, they found that RME resulted in both higher oxygen saturations (+ 5.3%) and improved AHI (- 4.2 events). The second study assessed 11 patients aged 5–8 years and also noted improvements, with mean AHI reduction from 6.1 to 2.4 and oxygen saturations increasing from 93.1% to 96.8%. The third study reviewed 14 patients aged 6–9 years and similarly found an AHI reduction from 5.7 to 4.4 and an oxygen saturation increase from 89.8% to 95.5%. All modifications noted in these studies were statistically significant. A long-term study reviewed 23 patients aged 6–12 years post-RME treatment on an annual basis for 12 years. They found that the mean AHI reduced from 12.2 to 0.4, with improved oxygen saturations from 78.9% to 95.1%. Another study assessed 19 patients aged 9-12 years at two months into RME and four months post-treatment. Improvements were also noted at both stages, with an overall reduction of the mean AHI from 16.3 to 0.8 and an overall increase in oxygen saturations from 77.9% to 95.4%. The final study assessed 26 children aged 7-11 years on completion of individual treatment and found an AHI reduction from 6.9 to 5.3. However, the oxygen saturation remained stagnant at 96.0%, but this was not clinically significant. Conclusion: Overall, the current evidence suggests that RME is a promising treatment option for paediatric patients with OSA. It can provide efficient and conservative treatment; however, early diagnosis is crucial. As there are various factors that could be contributing to OSA, it is important that each case is treated on its individual merits. Going forward, there is a need for more randomized control trials with larger cohorts being studied. Research into the long-term effects of RME and potential relapse amongst cases would also be useful.

Keywords: orthodontics, sleep apnea, maxillary expansion, review

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Authors: Isil Cakir, Mustafa Uluhan

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Elevated serum Cardiotrophin-1 (CT-1) and leptin levels are important risk factors for cardiovascular diseases (CVDs). Obstructive sleep apnea syndrome (OSAS) has been reported to increase the risk of CVDs, too. The aim of this study was to evaluate the concentrations of serum CT-1 and leptin in these patients and whether their possible association with the disease severity. Fifty newly diagnosed patients with OSAS and thirty nonapneic snoring subjects were participated in this study. The mean ages of patients and control groups were 47.40±13.30 and 43.23±10.50 years, respectively (P=0.128). Fasting serum triglyseride, total cholesterol, LDL and HDL cholesterol, also CT-1 and leptin levels were evaluated. A significant difference was found in the serum CT-1 and leptin levels between the patients and the controls:serum median CT-1 levels in patients and control groups, respectively, were 19.47 and 8.23 pg/mL (P < 0.001) and leptin levels were 2.07 and 1.29 ng/mL (P < 0.001). In severe patients group (n=39), serum median CT-1 level was found statistically significantly higher than the median level in mild/moderate patients (n=11) group. Patients CT-1 concentrations were not associated with lipoprotein levels and there was no correlation between patients’ leptin and lipid profile parameters. Two risk factors for CVDs, CT-1 and leptin, have significantly elevated and they were associated with OSAS. Furthermore, CT-1 was associated with the severity of disease. We recommend the use of increased serum CT-1 and leptin concentrations as markers of the presence and severity of OSAS.They can be used as early markers in male OSAS patients without known CVDs.

Keywords: obstructive sleep apnea syndrome, cardiotrophin-1, leptin, cardiovascular disease

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Authors: Semyachkina-Glushkovskaya Oxana, Fedosov Ivan, Blokhina Inna, Terskov Andrey, Evsukova Arina, Elovenko Daria, Adushkina Viktoria, Dubrovsky Alexander, Jürgen Kurths

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In modern neurobiology, sleep is considered a novel biomarker and a promising therapeutic target for brain diseases. This is due to recent discoveries of the nighttime activation of the brain lymphatic system (BLS), playing an important role in the removal of wastes and toxins from the brain and contributes neuroprotection of the central nervous system (CNS). In our review, we discuss that night stimulation of BLS might be a breakthrough strategy in a new treatment of Alzheimer’s and Parkinson’s disease, stroke, brain trauma, and oncology. Although this research is in its infancy, however, there are pioneering and promising results suggesting that night transcranial photostimulation (tPBM) stimulates more effectively lymphatic removal of amyloid-beta from mouse brain than daily tPBM that is associated with a greater improvement of the neurological status and recognition memory of animals. In our previous study, we discovered that tPBM modulates the tone and permeability of the lymphatic endothelium by stimulating NO formation, promoting lymphatic clearance of wastes and toxins from the brain tissues. We also demonstrate that tPBM can also lead to angio- and lymphangiogenesis, which is another mechanism underlying tPBM-mediated stimulation of BLS. Thus, photo-augmentation of BLS might be a promising therapeutic target for preventing or delaying brain diseases associated with BLS dysfunction. Here we present pioneering technology for simultaneous tPBM in humans and sleep monitoring for stimulation of BLS to remove toxins from CNS and modulation of brain immunity. The wireless-controlled gadget includes a flexible organic light-emitting diode (LED) source that is controlled directly by a sleep-tracking device via a mobile application. The designed autonomous LED source is capable of providing the required therapeutic dose of light radiation at a certain region of the patient’s head without disturbing of sleeping patient. To minimize patients' discomfort, advanced materials like flexible organic LEDs were used. Acknowledgment: This study was supported by RSF project No. 23-75-30001.

Keywords: brain diseases, brain lymphatic system, phototherapy, sleep

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Authors: B. Padmaja, V. V. Rama Prasad, K. V. N. Sunitha, E. Krishna Rao Patro

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Stress is a psychological condition that reduces the quality of sleep and affects every facet of life. Constant exposure to stress is detrimental not only for mind but also body. Nevertheless, to cope with stress, one should first identify it. This paper provides an effective method for the cognitive stress level detection by using data provided from a physical activity tracker device Fitbit. This device gathers people’s daily activities of food, weight, sleep, heart rate, and physical activities. In this paper, four major stressors like physical activities, sleep patterns, working hours and change in heart rate are used to assess the stress levels of individuals. The main motive of this system is to use machine learning approach in stress detection with the help of Smartphone sensor technology. Individually, the effect of each stressor is evaluated using logistic regression and then combined model is built and assessed using variants of ordinal logistic regression models like logit, probit and complementary log-log. Then the quality of each model is evaluated using Akaike Information Criterion (AIC) and probit is assessed as the more suitable model for our dataset. This system is experimented and evaluated in a real time environment by taking data from adults working in IT and other sectors in India. The novelty of this work lies in the fact that stress detection system should be less invasive as possible for the users.

Keywords: physical activity tracker, sleep pattern, working hours, heart rate, smartphone sensor

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Authors: Chun-Chuan Yang, Jeng-Yueng Chen, Yi-Ting Mai, Chen-Ming Yang

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In this paper, the design of integrated sleep scheduling for relay nodes and user equipments under a Donor eNB (DeNB) in the mode of Time Division Duplex (TDD) in LTE-A is presented. The idea of virtual time is proposed to deal with the discontinuous pattern of the available radio resource in TDD, and based on the estimation of the traffic load, three power saving schemes in the top-down strategy are presented. Associated mechanisms in each scheme including calculation of the virtual subframe capacity, the algorithm of integrated sleep scheduling, and the mapping mechanisms for the backhaul link and the access link are presented in the paper. Simulation study shows the advantage of the proposed schemes in energy saving over the standard DRX scheme.

Keywords: LTE-A, relay, TDD, power saving

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Authors: C. Fernandez-Plaza, I. Abad, E. Diaz, I. Diaz

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Births occurring before the 37th week of gestation are considered preterm births. A threat of preterm is defined as the beginning of regular uterine contractions, dilation and cervical effacement between 23 and 36 gestation weeks. To author's best knowledge, the factors that determine the beginning of the birth are not completely defined yet. In particular, the incidence of sleep habits on preterm births is weekly studied. The aim of this study is to develop a model to predict the factors affecting premature delivery on pregnancy, based on the above potential risk factors, including those derived from sleep habits and light exposure at night (introduced as 12 variables obtained by a telephone survey using two questionnaires previously used by other authors). Thus, three groups of variables were included in the study (maternal, fetal and sleep habits). The study was approved by Research Ethics Committee of the Principado of Asturias (Spain). An observational, retrospective and descriptive study was performed with 481 births between January 1, 2015 and May 10, 2016 in the University Central Hospital of Asturias (Spain). A statistical analysis using SPSS was carried out to compare qualitative and quantitative variables between preterm and term delivery. Chi-square test qualitative variable and t-test for quantitative variables were applied. Statistically significant differences (p < 0.05) between preterm vs. term births were found for primiparity, multi-parity, kind of conception, place of residence or premature rupture of membranes and interruption during nights. In addition to the statistical analysis, machine learning methods to look for a prediction model were tested. In particular, tree based models were applied as the trade-off between performance and interpretability is especially suitable for this study. C5.0, recursive partitioning, random forest and tree bag models were analysed using caret R-package. Cross validation with 10-folds and parameter tuning to optimize the methods were applied. In addition, different noise reduction methods were applied to the initial data using NoiseFiltersR package. The best performance was obtained by C5.0 method with Accuracy 0.91, Sensitivity 0.93, Specificity 0.89 and Precision 0.91. Some well known preterm birth factors were identified: Cervix Dilation, maternal BMI, Premature rupture of membranes or nuchal translucency analysis in the first trimester. The model also identifies other new factors related to sleep habits such as light through window, bedtime on working days, usage of electronic devices before sleeping from Mondays to Fridays or change of sleeping habits reflected in the number of hours, in the depth of sleep or in the lighting of the room. IF dilation < = 2.95 AND usage of electronic devices before sleeping from Mondays to Friday = YES and change of sleeping habits = YES, then preterm is one of the predicting rules obtained by C5.0. In this work a model for predicting preterm births is developed. It is based on machine learning together with noise reduction techniques. The method maximizing the performance is the one selected. This model shows the influence of variables related to sleep habits in preterm prediction.

Keywords: machine learning, noise reduction, preterm birth, sleep habit

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Authors: Paulina Ojeda, Damaris Estrella, Hector Rubio

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Insomnia is a disorder characterized by difficulty falling asleep, staying asleep or both. It negatively affects the life quality of people, it hinders the concentration, attention, memory, motor skills, among other abilities that complicate work or learning. Some studies show that women are more susceptible to insomnia. Medicine curricula usually involve a great deal of theoretical and memory content, especially in the early years of the course. The way to accredit a university course is to demonstrate the level of competence or acquired knowledge. In Mexico the most widely used form of measurement is written exams, with numerical scales results. The prevalence of sleep disorders in university students is usually high, so it is important to know if insomnia has an effect on school performance in men and women. A cross-sectional study was designed that included a probabilistic sample of 118 regular students from the School of Medicine of the Autonomous University of Yucatan, Mexico. All on legally age. The project was authorized by the School of Medicine and all the ethical implications of the case were monitored. Participants completed anonymously the following questionnaires: Pittsburgh Sleep Quality Index, Insomnia Severity Index, AUDIT test, epidemiological and clinical data. Academic performance was assessed by the average number of official grades earned on written exams, as well as the number of approved or non-approved courses. These data were obtained officially through the corresponding school authorities. Students with at least one unapproved course or average less than 70 were considered to be poor performers. With all courses approved and average between 70-79 as regular performance and with an average of 80 or higher as a good performance. Statistical analysis: t-Student, difference of proportions and ANOVA. 65 men with a mean age of 19.15 ± 1.60 years and 53 women of 18.98 ± 1.23 years, were included. 96% of the women and 78.46% of the men sleep in the family home. 16.98% of women and 18.46% of men consume tobacco. Most students consume caffeinated beverages. 3.7% of the women and 10.76% of the men complete criteria of harmful consumption of alcohol. 98.11% of the women and 90.76% of the men are perceived with poor sleep quality. Insomnia was present in 73% of women and 66% of men. Women had higher levels of moderate insomnia (p=0.02) compared to men and only one woman had severe insomnia. 50.94% of the women and 44.61% of the men had poor academic performance. 18.86% of women and 27% of men performed well. Only in the group of women we found a significant association between poor performance with mild (p= 0.0035) and moderate (p=0.031) insomnia. The medical students reported poor sleep quality and insomnia. In women, levels of insomnia were associated with poor academic performance.

Keywords: scholar-average, sex, sleep, university

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Authors: Patikineti Sreenivasulu, K. srinivasa Rao, A. Vinaya Babu

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The demand for portability, performance and high functional integration density of digital devices leads to the scaling of complementary metal oxide semiconductor (CMOS) devices inevitable. The increase in power consumption, coupled with the increasing demand for portable/hand-held electronics, has made power consumption a dominant concern in the design of VLSI circuits today. MTCMOS technology provides low leakage and high performance operation by utilizing high speed, low Vt (LVT) transistors for logic cells and low leakage, high Vt (HVT) devices as sleep transistors. Sleep transistors disconnect logic cells from the supply and/or ground to reduce the leakage in the sleep mode. In this technology, energy consumption while doing the mode transition and minimum time required to turn ON the circuit upon receiving the wake up signal are issues to be considered because these can adversely impact the performance of VLSI circuit. In this paper we are introducing an enhancing method of MTCMOS technology to optimize the power in MTCMOS sequential circuits.

Keywords: power consumption, ultra-low power, leakage, sub threshold, MTCMOS

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Authors: K. Shiba, T. Kobayashi, T. Kaburagi, Y. Kurihara

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Elderly population in the world is increasing, and consequently, their nursing burden is also increasing. In such situations, monitoring and evaluating their daily action facilitates efficient nursing care. Especially, we focus on an unconscious activity during sleep, i.e. turnover. Monitoring turnover during sleep is essential to evaluate various conditions related to sleep. Bedsores are considered as one of the monitoring conditions. Changing patient’s posture every two hours is required for caregivers to prevent bedsore. Herein, we attempt to develop an unconstrained nocturnal monitoring system using a sensing device based on piezoelectric ceramics that can detect the vibrations owing to human body movement on the bed. In the proposed method, in order to construct a multi-points sensing, we placed two sensing devices under the right and left legs at the head-side of an ordinary bed. Using this equipment, when a subject lies on the bed, feature is calculated from the output voltages of the sensing devices. In order to evaluate our proposed method, we conducted an experiment with six healthy male subjects. Consequently, the period during which turnover occurs can be correctly classified as the turnover period with 100% accuracy.

Keywords: turnover, piezoelectric ceramics, multi-points sensing, unconstrained monitoring system

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Authors: Li Yuan

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Objective: The combination of group psychology and Sertraline was used to explore the impact on the mental health status of adolescent patients with first-episode depression. Methods: A total of 118 adolescent depressed patients admitted to Yan'an University Hospital from October 2023 to August 2024 were divided into control group and observation group by random single blind method with 59 patients in each group. The two groups were treated with Sertraline, the control group received usual care, and the observation group used the usual care. The scores of mental health status and sleep quality index were compared between the two groups. Results: In intra-group comparison, the mental health status and sleep quality of the observation and control groups were better than the pre-intervention scores, and the difference was statistically significant (P <0.05). Post-intervention comparison: HAMA and HAMD scores were (12.36 ± 2.13) and (11.78 ± 2.02), significantly lower than (16.52 ± 2.09) and (15.79 ± 2.46), respectively (all P <0.05); PSQI score was (7.66 ± 1.05) and significantly lower (9.88 ± 3.01), with statistically significant difference (P <0.05). Conclusion: Self-regulation can improve their mental health and sleep quality.

Keywords: group psychotherapy, Sertraline, adolescent, depression, mental health status

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Authors: Maria Korman, Carmit Gal, Ella Gabitov, Avi Karni

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The main question addressed in this study was whether the time-of-day wherein training is afforded is a significant factor for motor skill ('how-to', procedural knowledge) acquisition and consolidation into long term memory in the healthy elderly population. Twenty-nine older adults (60-75 years) practiced an explicitly instructed 5-element key-press sequence by repeatedly generating the sequence ‘as fast and accurately as possible’. Contribution of three parameters to acquisition, 24h post-training consolidation, and 1-week retention gains in motor sequence speed was assessed: (a) time of training (morning vs. evening group) (b) sleep quality (actigraphy) and (c) chronotype. All study participants were moderately morning type, according to the Morningness-Eveningness Questionnaire score. All participants had sleep patterns typical of age, with average sleep efficiency of ~ 82%, and approximately 6 hours of sleep. Speed of motor sequence performance in both groups improved to a similar extent during training session. Nevertheless, evening group expressed small but significant overnight consolidation phase gains, while morning group showed only maintenance of performance level attained at the end of training. By 1-week retention test, both groups showed similar performance levels with no significant gains or losses with respect to 24h test. Changes in the tapping patterns at 24h and 1-week post-training were assessed based on normalized Pearson correlation coefficients using the Fisher’s z-transformation in reference to the tapping pattern attained at the end of the training. Significant differences between the groups were found: the evening group showed larger changes in tapping patterns across the consolidation and retention windows. Our results show that morning-oriented older adults effectively acquired, consolidated, and maintained a new sequence of finger movements, following both morning and evening practice sessions. However, time-of-training affected the time-course of skill evolution in terms of performance speed, as well as the re-organization of tapping patterns during the consolidation period. These results are in line with the notion that motor training preceding a sleep interval may be beneficial for the long-term memory in the elderly. Evening training should be considered an appropriate time window for motor skill learning in older adults, even in individuals with morning chronotype.

Keywords: time-of-day, elderly, motor learning, memory consolidation, chronotype

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Authors: Samereh Abdoli, Amit Vora, Anusha Vora

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Aim: To qualitatively investigate diabetes burnout in parents of children with Type 1 Diabetes (T1D) who shared their experiences through YouTube videos in order to inform future interventions and improve diabetes practice. Methods: A qualitative descriptive approach was used to explore YouTube videos. Of the 568 videos that were identified, only 9 videos met the inclusion criteria of the study. Results: After the videos were transcribed and analyzed using qualitative content analysis, it was revealed that parents shared common concerns and experiences and they translated into three main themes: I do not ever get a break, I am exhausted, I can’t burn out, and I just need a break Conclusion: All in all, the literature revealed that there are negative psychosocial outcomes associated with caring for a child with T1D, but there is a lack of information on diabetes burnout and how parents’ well-being are affected. Reports of self-neglect and sleep deprivation only confirm the need for intervention for parents of children with T1D. The hope with this study is that burnout can be recognized early on and appropriate interventions put in place to help parents cope with the stressors of caring for a child with a chronic disease.

Keywords: Diabetes burnout, type 1 diabetes, qualitative research, parents

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Authors: Lukasz Baka

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Objective. The study aimed to investigate the direct and indirect - mediated through insomnia - effect of coronavirus anxiety on exhaustion from the perspective of Hobfol Conservation of Resources (COR) theory. According to COR theory, critical events (e.g. the coronavirus epidemic) make people fearful of losing their valuable resources. A prolonged state of anxiety may lead to sleep troubles, which over time, results in an increase in exhaustion. Materials and Methods: Data were collected among 440 Polish healthcare providers, including nurses and midwives, doctors, paramedics, medical assistance, and wardens. Three measurements were used: Coronavirus Anxiety Scale (CAS), Copenhagen Psychosocial Questionnaire (COPSOQ, sleep trouble subscale) and Oldenburg Burnout Inventory (OLBI, exhaustion subscale). Hypotheses were tested by the use of Structural Equation Modelling (SEM). Results: The obtained results fully support the hypotheses. Both the direct and indirect relationships between coronavirus anxiety and exhaustion were observed. Specifically, high coronavirus anxiety increased insomnia, which in turn contributed to the development of exhaustion. Conclusion: The results are consistent with the COR theory. Prolonged coronavirus anxiety and sleep problems depleted healthcare providers’ resources and made them feel exhausted. Exhaustion among these workers can have serious consequences not only for themselves but also for the health of their patients, therefore researches into effective ways to deal with coronavirus anxiety are needed.

Keywords: coronavirus anxiety, front-line healt-care workers, insomnia, job burnout

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Authors: Lauren Booker

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In the United States, over 2.5 million children have incarcerated parents. Recent studies have shown 13% of young adults and one-fourth of African Americans will experience parental incarceration. The increasing numbers of incarcerated citizens have left these children as collateral damage and are often forgotten, their special needs inadequately meet or understood. Parental arrest and incarceration creates a uniquely traumatic experience in childhood and has long-term consequences for these children. Until recently, the eating and sleeping habits following parental incarceration had been nonexistent in the literature. However, even this groundbreaking study on eating habits and sleeping disorders following parental incarceration did not touch on the root causes of unhealthy eating which may be influenced by food and housing insecurity and environmental factors that may impact a child’s healthy eating and sleeping behaviors. This study will examine those factors as it could greatly aid in the policies and programs that affect children’s health and development. This proposed study will examine the impact of traumatic stress reactions to parental incarceration by studying sleep and eating habits as the hypothesis is that parental incarceration will lead to disordered eating and sleep disturbances in early adolescents.

Keywords: parental incarceration, eating disorder, trauma, family instability

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Authors: Wilfred Elliam

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Background: Pain is a prevalent and debilitating symptom among breast cancer patients, impacting their quality of life and overall well-being. The experience of pain in this population is multifaceted, influenced by a combination of disease-related factors, treatment side effects, and individual characteristics. Despite advancements in cancer treatment and pain management, many breast cancer patients continue to suffer from chronic pain, which can persist long after the completion of treatment. Understanding the progression of pain in breast cancer patients over time and identifying its correlates is crucial for effective pain management and supportive care strategies. The purpose of this research is to understand the patterns and progression of pain experienced by breast cancer survivors over time. Methods: Data were collected from breast cancer patients at Hartford Hospital at four time points: baseline, 3, 6 and 12 weeks. Key variables measured include pain, body mass index (BMI), fatigue, musculoskeletal pain, sleep disturbance, and demographic variables (age, employment status, cancer stage, and ethnicity). Binomial generalized linear mixed models were used to examine changes in pain and symptoms over time. Results: A total of 100 breast cancer patients aged  18 years old were included in the analysis. We found that the effect of time on pain (p = 0.024), musculoskeletal pain (p= <0.001), fatigue (p= <0.001), and sleep disturbance (p-value = 0.013) were statistically significant with pain progression in breast cancer patients. Patients using aromatase inhibitors have worse fatigue (<0.05) and musculoskeletal pain (<0.001) compared to patients with Tamoxifen. Patients who are obese (<0.001) and overweight (<0.001) are more likely to report pain compared to patients with normal weight. Conclusion: This study revealed the complex interplay between various factors such as time, pain, sleep disturbance in breast cancer patient. Specifically, pain, musculoskeletal pain, sleep disturbance, fatigue exhibited significant changes across the measured time points, indicating a dynamic pain progression in these patients. The findings provide a foundation for future research and targeted interventions aimed at improving pain in breast cancer patient outcomes.

Keywords: breast cancer, chronic pain, pain management, quality of life

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Authors: Ching-Yi Yiu, Hui-Chen Hsu

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Objectives: Obstructive sleep apnea syndrome (OSAS) is a popular problem in the modern society. It usually leads to sleep disorder, excessive daytime sleepiness and associated with cardiovascular diseases, cognitive dysfunction and even death. The nonsurgical therapies include continuous positive airway pressure (CPAP), diet and oral appliances. The surgical approaches have nasal surgery, tonsillectomy, adenoidectomy, uvulopalatopharyngoplasty (UPPP) and transoral robotic surgery (TORS).We compare the impact of surgical treatments on these kinds of patients. Methods: Between January 2018 to September 2022, We have enrolled 125 OSAS patients including 82 male and 43 female in Chi Mei Medical Center, Liouying, Taiwan. The age distribution from 6 to 71 years old (y/o) with mean age 36.1 y/o. The averaged body mass index (BMI) is 25 kg/m2 in male and 25.5 kg/m2 in female. In this cohort, we evaluated their upper airway obstruction sites with nasopharyngoscopy and scheduled a planned surgery. Some of cases received polysomnography (PSG) preoperatively, the averaged apnea-hypopnea index (AHI) is 37.7 events/hour. We have 68 patients received tonsillectomy, 9 received UPPP, 42 received UPPP and septomeatoplasty (SMP) and 6 received adenoidectomy and tonsillectomy (A and T). The subjective daytime sleepiness was evaluated with the Epworth sleepiness scale (ESS). Results: In the 68 tonsillectomy group, the averaged BMI is 24.9 kg/m2. In the UPPP group, the averaged BMI is 28.9 kg/m2. In UPPP and SMP group, the averaged BMI is 27.9 kg/m2. In the A and T group, the averaged BMI is 17.2 kg/m2. The reduction of AHI less than 20 is 58% postoperatively. The ESS reduced from 10.9 to 4.9 after surgery. Conclusion: Obstructive sleep apnea syndrome is a common upper airway disturbance in the general population. The prevalence rate is ranging high depending on different regions, age, sex and race. It leads to severe morbidity and mortality including car accident, stroke, nocturnal desaand sudden death and should be considered to be a major public health problem. The CPAP is effective to improve daytime sleepiness but the long-term compliance is low. The surgical treatment with different modalities can produce 50% decrease in AHI and ESS after surgery in the 6 to 12 months short-term period.

Keywords: apnea-hypopnea index, obstructive sleep apnea syndrome, polysomnography, uvulopalatopharyngoplasty

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Authors: Sonda Jallouli, Sameh Ghroubi, Salma Sakka, Abdelmoneem Yahia, Mohamed Habib Elleuch, Imen Ben Dhia, Chokri Mhiri, Omar Hammouda

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The pathophysiology, prevalence, and progression of MS are gender dependent. Indeed, the inflammation is more pronounced in women, but the neurodegeneration is more important in men. In addition, women have more sleep disorders while men suffer more from cognitive decline. These non-physical disorders can negatively affect postural balance and fall risk. However, no study has examined the difference between men and women in those physical parameters in MS. Our objective was to determine the effect gender difference on postural balance and fall risk in MS persons. Methods: Eight men and twelve women with relapsing remitting-MS participated in this study. The assessment includes a posturographic examination to assess static (with eyes opened (EO) and eyes closed (EC)) and dynamic (with EO) postural balance. Unipedal balance and fall risk were assessed by a clinical unipedal balance test and the Four Square Step Test, respectively. Sleep quality was assessed using Spiegel's questionnaire, and cognitive assessment was performed using the Montreal Cognitive Assessment (MoCA) and the Simple Reaction Time Test. Results: Compared to men, women showed an increase in CdPVm in static bipedal condition with EC (p=0.037; d=0.71) and a decrease in MoCA scores (p=0.028; d=1.06). No gender differences were found in the other tests. Discussion: Static postural balance was more impaired in women compared to men. This result could be explained by the more pronounced cognitive decline observed in women compared to men. Indeed, cognitive disorders have been shown to be predictive factors of postural balance impairment. Conclusion: women were less stable than men in the static condition, possibly due to their lower cognitive performance. This gender difference could be taken into account by therapists in training programs.

Keywords: multiple sclerosis, bipedal postural balance, fall risk, sleep disturbance, cognitive deficiency

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Authors: Khader A. Almhdawi, Hassan Alrabbaie

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Background: Musculoskeletal disorders (MSDs) represent a significant challenge for registered nurses. To our best knowledge, there is no published study that investigated the prevalence of MSDs among nurses and their associated factors comprehensively in Jordan. This study aimed to find the prevalence of MSDs, their possible predictors among registered nurses in Jordanian hospitals. Methods: A cross-sectional design was used. Outcome measures included Nordic Musculoskeletal Questioner (NMQ), Depression Anxiety Stress Scale (DASS), Pittsburgh Sleep Quality Index (PSQI), IPAQ, and sociodemographic data. Prevalence of musculoskeletal complaints was reported using descriptive analysis. Logistic regression analyses were conducted to identify predictors of MSDs. Results: 597 nurses from different hospitals in Jordan participated in this study. Reported MSDs prevalence was the highest at neck (61.1%), followed by upper back (47.2%), shoulder (46.7%), wrist and hands (27.3%), and elbow (13.9%). Significant predictors of MSDs among Jordanian nurses included: being a female, poor sleep quality, high physical activity levels, poor ergonomics, increased workload, and mental stress. Conclusion: This study showed a high prevalence of MSDs among Jordanian nurses and identified their significant predictors. Future studies are needed to investigate the progressive nature of MSDs and their effective treatment strategies.

Keywords: musculoskeletal disorders, nursing, ergonomic, occupational stress

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Authors: Ziyu Zhang, Xuanyu Ren, Fei Wu, Qinfei Lu, Yongmei Li, Xinyue Zhi

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Introduction: Adolescents experience a critical period of physical and psychological growth. Few studies focus on the influence of sleep hygiene on psychological health from the high school period to freshmen year. Also, the influence of the COVID-19 pandemic has public health significance. Methods: Totally 698 students from high school and college were included in the manuscript, and a cross-sectional procedure was conducted; the objective was to make the epidemiological comparison of the social phobia/depression prevalence and discuss the effects of potential determinants. Results: Psychological problems, including social phobia and depression, are prevalent, especially among high school students, with gender differences. The current results indicated that the association between sleep status and social phobia is most obvious among high school students, while the higher MMR risk was found both for high school social phobia students and college depressive freshmen. Moreover, the interaction between social phobia and depression was also obvious for both populations. Conclusions: Psychological problems, including social phobia and depression, are more prevalent among high school girls when compared with their male and freshmen peers. Important influenced factors for the risk of psychological problems among the two populations were different, but media multitasking status should be paid attention to for both.

Keywords: adolescence, psychological health, epidemiology, social culture

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Authors: Ghada A. Abdelbary, Maha M. Amin, Mostafa Abdelmoteleb

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Zaleplon (ZP) is a non-benzodiazepine poorly soluble hypnotic drug indicated for the short term treatment of insomnia having a bioavailability of about 30%. The aim of the present study is to enhance the solubility and consequently the bioavailability of ZP using hydrotropic agents (HA). Phase solubility diagrams of ZP in presence of different molar concentrations of HA (Sodium benzoate, Urea, Ascorbic acid, Resorcinol, Nicotinamide, and Piperazine) were constructed. ZP/Sodium benzoate and Resorcinol microparticles were prepared adopting melt, solvent evaporation and melt-evaporation techniques followed by XRD. Directly compressed mixed hydrotropic ZP tablets of Sodium benzoate and Resorcinol in different weight ratios were prepared and evaluated compared to the commercially available tablets (Sleep aid® 5 mg). The effect of shelf and accelerated stability storage (40°C ± 2°C/75%RH ± 5%RH) on the optimum tablet formula (F5) for six months were studied. The enhancement of ZP solubility follows the order of: Resorcinol > Sodium benzoate > Ascorbic acid > Piperazine > Urea > Nicotinamide with about 350 and 2000 fold increase using 1M of Sodium benzoate and Resorcinol respectively. ZP/HA microparticles exhibit the order of: Solvent evaporation > melt-solvent evaporation > melt > physical mixture which was further confirmed by the complete conversion of ZP into amorphous form. Mixed hydrotropic tablet formula (F5) composed of ZP/(Resorcinol: Sodium benzoate 4:1w/w) microparticles prepared by solvent evaporation exhibits in-vitro dissolution of 31.7±0.11% after five minutes (Q5min) compared to 10.0±0.10% for Sleep aid® (5 mg) respectively. F5 showed significantly higher GABA concentration of 122.5±5.5mg/mL in plasma compared to 118±1.00 and 27.8±1.5 mg/mL in case of Sleep aid® (5 mg) and control taking only saline respectively suggesting a higher neuropharmacological effect of ZP following hydrotropic solubilization.

Keywords: zaleplon, hydrotropic solubilization, plasma GABA level, mixed hydrotropy

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