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Sleep, Stress, and Symptoms Among People With Heart Failure During the COVID-19 Pandemic.
O'Connell, M, Jeon, S, Conley, S, Linsky, S, Redeker, NS
The Journal of cardiovascular nursing. 202301;38(2):E55-E60
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COVID-19 pandemic raised concerns about the effects of stress on mental health and sleep deficiency. Cognitive behavioural therapy for insomnia (CBT-I) has been shown to improve sleep quality and insomnia severity, as well as anxiety and depression, and may be protective during times of stress, including the COVID-19 pandemic. The aim of this study was to examine changes in sleep, sleep-related cognitions, stress, anxiety, and depression among people with heart failure (HF). This study was a randomised controlled trial of the effects of CBT-I compared with HF self-management education (attention-control condition), the “HeartSleep Study.” Results showed that improvements in insomnia severity, sleep quality, latency, and efficiency, sleep-related cognitions and stress, anxiety, and depression after participation in CBT-I or an HF self-management class were sustained during the pandemic. Authors conclude that their findings confirm the clinical benefits of CBT-I for people with HF and comorbidities and also suggest the potential benefits of HF self-management education.
Abstract
BACKGROUND The COVID-19 pandemic raised concerns about the effects of stress on sleep and mental health, particularly among people with chronic conditions, including people with heart failure (HF). OBJECTIVE The aim of this study was to examine changes in sleep, sleep-related cognitions, stress, anxiety, and depression among people with HF who participated in a randomized controlled trial of cognitive behavioral therapy for insomnia before the COVID-19 pandemic. METHODS Participants self-reported sleep characteristics, symptoms, mood, and stress at baseline, 6 months after cognitive behavioral therapy for insomnia or HF self-management education (attention control), and during the pandemic. RESULTS The sample included 112 participants (mean age, 63 ± 12.9 years; 47% women; 13% Black; 68% New York Heart Association class II or III). Statistically significant improvements in sleep, stress, mood, and symptoms that occurred 6 months post treatment were sustained during the pandemic. CONCLUSIONS Improving sleep and symptoms among people with HF may improve coping during stressful events, and cognitive behavioral therapy for insomnia may be protective.
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Time of the day of exercise impact on cardiovascular disease risk factors in adults: a systematic review and meta-analysis.
Sevilla-Lorente, R, Carneiro-Barrera, A, Molina-Garcia, P, Ruiz, JR, Amaro-Gahete, FJ
Journal of science and medicine in sport. 2023;26(3):169-179
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In humans, shifted sleep patterns seem to interfere with several metabolic pathways. Shift work, short sleep duration, exposure to artificial light, inadequate eating time window, and lack of physical activity, are some characteristics of the modern lifestyle that contributes to the occurrence and worsening of cardiovascular disease (CVD). The aim of this study was to analyse the time of the day of exercise-induced effects on CVD risk factors in adults. This study was a systematic review and meta-analysis of twenty-two studies. Results showed that exercise produces an acute reduction of systolic blood pressure independently of the time of the day at which it is performed. Similarly, exercise produces an acute increase in blood glucose independently of the time of the day. Authors concluded that further research is needed to establish whether there is a diurnal variation of exercise on cardiovascular health and how it is related to health status, sex, or the type of exercise.
Abstract
OBJECTIVES To compare the effect of a single bout of morning vs. evening exercise on cardiovascular risk factors in adults. DESIGN Systematic review and meta-analysis. METHODS A systematic search of studies was conducted using PubMed and Web of Science from inception to June 2022. Selected studies accomplished the following criteria: crossover design, acute effect of exercise, blood pressure, blood glucose, and/or blood lipids as the study's endpoint, a washout period of at least 24 h, and adults. Meta-analysis was performed by analyzing: 1) separated effect of morning and evening exercise (pre vs. post); and 2) comparison between morning and evening exercise. RESULTS A total of 11 studies were included for systolic and diastolic blood pressure and 10 studies for blood glucose. Meta-analysis revealed no significant difference between morning vs. evening exercise for systolic blood pressure (g ∆ = 0.02), diastolic blood pressure (g ∆ = 0.01), or blood glucose (g ∆ = 0.15). Analysis of moderator variables (age, BMI, sex, health status, intensity and duration of exercise, and hour within the morning or evening) showed no significant morning vs. evening effect. CONCLUSIONS Overall, we found no influence of the time of the day on the acute effect of exercise on blood pressure neither on blood glucose.
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Causal relationship between nonalcoholic fatty liver disease and different sleep traits: a bidirectional Mendelian randomized study.
Sun, Z, Ji, J, Zuo, L, Hu, Y, Wang, K, Xu, T, Wang, Q, Cheng, F
Frontiers in endocrinology. 2023;14:1159258
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Non-alcoholic fatty liver disease (NAFLD) is caused by a build up of fat in the liver. NAFLD is becoming more common, with the rise in rates of obesity. There are no specific medications available for NAFLD and patients are advised to manage their diets and lifestyle following diagnosis. The aim of this study was to assess and evaluate the causal relationship between sleep and NAFLD. The study was a two-way Mendelian randomised clinical trial. Results showed that different sleep traits can be the cause of the onset and exacerbation of NAFLD. NAFLD does not change sleep traits and the causal relationship between them is unidirectional. Authors conclude that sleep characteristics are associated with an elevated risk of NAFLD. Thus, enhancing sleep should be considered by healthcare practitioners as part of prevention and management NAFLD.
Abstract
BACKGROUND AND AIMS Non-alcoholic fatty liver disease(NAFLD) is common worldwide and has previously been reported to be associated with sleep traits. However, it is not clear whether NAFLD changes sleep traits or whether the changes in sleep traits lead to the onset of NAFLD. The purpose of this study was to investigate the causal relationship between NAFLD and changes in sleep traits using Mendelian randomization. METHODS We proposed a bidirectional Mendelian randomization (MR) analysis and performed validation analyses to dissect the association between NAFLD and sleep traits. Genetic instruments were used as proxies for NAFLD and sleep. Data of genome-wide association study(GWAS) were obtained from the center for neurogenomics and cognitive research database, Open GWAS database and GWAS catalog. Three MR methods were performed, including inverse variance weighted method(IVW), MR-Egger, weighted median. RESULTS In total,7 traits associated with sleep and 4 traits associated with NAFLD are used in this study. A total of six results showed significant differences. Insomnia was associated with NAFLD (OR(95% CI)= 2.25(1.18,4.27), P = 0.01), Alanine transaminase levels (OR(95% CI)= 2.79(1.70, 4.56), P =4.71×10-5) and percent liver fat(OR(95% CI)= 1.31(1.03,1.69), P = 0.03). Snoring was associated with percent liver fat (1.15(1.05,1.26), P =2×10-3), alanine transaminase levels (OR(95% CI)= 1.27(1.08,1.50), P =0.04).And dozing was associated with percent liver fat(1.14(1.02,1.26), P =0.02).For the remaining 50 outcomes, no significant or definitive association was yielded in MR analysis. CONCLUSION Genetic evidence suggests putative causal relationships between NAFLD and a set of sleep traits, indicating that sleep traits deserves high priority in clinical practice. Not only the confirmed sleep apnea syndrome, but also the sleep duration and sleep state (such as insomnia) deserve clinical attention. Our study proves that the causal relationship between sleep characteristics and NAFLD is the cause of the change of sleep characteristics, while the onset of non-NAFLD is the cause of the change of sleep characteristics, and the causal relationship is one-way.
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The Emergency Medical Services Sleep Health Study: A cluster-randomized trial.
Patterson, PD, Martin, SE, Brassil, BN, Hsiao, WH, Weaver, MD, Okerman, TS, Seitz, SN, Patterson, CG, Robinson, K
Sleep health. 2023;9(1):64-76
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Severe mental and physical fatigue in shift work occupations is widespread, and workplace fatigue impacts a great majority of the Emergency Medical Services (EMS) clinician first responders. The hypothesis of this study was that education and training focused on sleep health and fatigue, delivered in an asynchronous manner and tailored to EMS shift workers, would result in improvements in sleep quality and a reduction in self-reported fatigue after a 3-month study interval. This study was a cluster-randomised, 2-arm randomised trial with a wait-list control group. EMS agencies (clusters) were randomised to either the intervention group or a wait-list control group. Results showed that intention-to-treat analyses revealed no differences in measures of sleep quality or fatigue at 3 months or 6 months follow-up. Per protocol analyses showed that the greater the number of education modules viewed, the greater the improvement in sleep quality and the greater the reduction in fatigue at 3-month follow-up. Authors conclude that the findings of this study may be useful to EMS administrators when designing fatigue risk management programmes.
Abstract
BACKGROUND Greater than half of emergency medical services (EMS) clinician shift workers report poor sleep, fatigue, and inadequate recovery between shifts. We hypothesized that EMS clinicians randomized to receive tailored sleep health education would have improved sleep quality and less fatigue compared to wait-list controls after 3 months. METHODS We used a cluster-randomized, 2-arm, wait-list control study design (clinicaltrials.gov identifier: NCT04218279). Recruitment of EMS agencies (clusters) was nationwide. Our study was powered at 88% to detect a 0.4 standard deviation difference in sleep quality with 20 agencies per arm and a minimum of 10 individuals per agency. The primary outcome was measured using the Pittsburgh Sleep Quality Index (PSQI) at 3-month follow-up. Our intervention was accessible in an online, asynchronous format and comprised of 10 brief education modules that address fatigue mitigation topics prescribed by the American College of Occupational Environmental Medicine. RESULTS In total, 36 EMS agencies and 678 individuals enrolled. Attrition at 3 months did not differ by study group (Intervention = 17.4% vs. Wait-list control = 18.2%; p = .37). Intention-to-treat analyses detected no differences in PSQI and fatigue scores at 3 months. Per protocol analyses showed the greater the number of education modules viewed, the greater the improvement in sleep quality and the greater the reduction in fatigue (p < .05). CONCLUSIONS While intention-to-treat analyses revealed no differences in sleep quality or fatigue at 3 months, per protocol findings identified select groups of EMS clinician shift workers who may benefit from sleep health education. Our findings may inform fatigue risk management programs.
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Effects of sleep fragmentation and partial sleep restriction on heart rate variability during night.
Schlagintweit, J, Laharnar, N, Glos, M, Zemann, M, Demin, AV, Lederer, K, Penzel, T, Fietze, I
Scientific reports. 2023;13(1):6202
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Adequate sleep is essential for physical and mental health and wellbeing. This randomised cross-over study of 20 healthy men compared the effects of sleep restriction (sleeping 5 instead of 8 hours) and sleep fragmentation (being woken hourly during the 8-hour sleeping time) on heart rate (HR) and heart rate variability (HRV), both markers of the sympathetic (“fight or flight”) and parasympathetic (“rest and digest”) arms of the autonomic nervous system. Sleep restriction increased HR and decreased HRV, suggesting increased sympathetic and decreased parasympathetic activation. This affected the lighter sleep phases in particular. Sleep fragmentation, on the other hand, did not affect HR or HRV compared to baseline. The authors conclude that sleep restriction may cause more stress than sleep fragmentation.
Abstract
We developed a cross-over study design with two interventions in randomized order to compare the effects of sleep fragmentation and partial sleep restriction on cardiac autonomic tone. Twenty male subjects (40.6 ± 7.5 years old) underwent overnight polysomnography during 2 weeks, each week containing one undisturbed baseline night, one intervention night (either sleep restriction with 5 h of sleep or sleep fragmentation with awakening every hour) and two undisturbed recovery nights. Parameters of heart rate variability (HRV) were used to assess cardiac autonomic modulation during the nights. Sleep restriction showed significant higher heart rate (p = 0.018) and lower HRV-pNN50 (p = 0.012) during sleep stage N1 and lower HRV-SDNN (p = 0.009) during wakefulness compared to the respective baseline. For HR and SDNN there were recovery effects. There was no significant difference comparing fragmentation night and its baseline. Comparing both intervention nights, sleep restriction had lower HRV high frequency (HF) components in stage N1 (p = 0.018) and stage N2 (p = 0.012), lower HRV low frequency (LF) (p = 0.007) regarding the entire night and lower SDNN (p = 0.033) during WASO during sleep. Sleep restriction increases sympathetic tone and decreases vagal tone during night causing increased autonomic stress, while fragmented sleep does not affect cardiac autonomic parameters in our sample.
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Effect of Sleep Changes on Health-Related Quality of Life in Healthy Children: A Secondary Analysis of the DREAM Crossover Trial.
Taylor, RW, Haszard, JJ, Jackson, R, Morrison, S, Beebe, DW, Meredith-Jones, KA, Elder, DE, Galland, BC
JAMA network open. 2023;6(3):e233005
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While inadequate or poor-quality sleep has been associated with a wide range of adverse physical and psychological health outcomes in infants, children and adolescents, interest is growing regarding the association of sleep with more global indices of health, such as health-related quality of life (HRQOL). The aim of this study was to determine the effect of mild sleep deprivation on HRQOL in children without major sleep issues. This study was a secondary analysis based on the DREAM randomised crossover trial. Children were randomised to one of two groups (sleep restriction or sleep extension) with a 1-week washout in between. Bedtimes were manipulated to be 1 hour later (sleep restriction) and 1 hour earlier (sleep extension) than usual for 1 week each. Wake times were unchanged. Results showed that after only 1 week of receiving 39 minutes less sleep per night between sleep conditions, children reported significantly lower HRQOL in terms of their physical and overall well-being and ability to cope well at school. Authors conclude that ensuring children receive sufficient good-quality sleep is an important child health issue.
Abstract
IMPORTANCE Little is known regarding the effect of poor sleep on health-related quality of life (HRQOL) in healthy children. OBJECTIVE To determine the effect of induced mild sleep deprivation on HRQOL in children without major sleep issues. DESIGN, SETTING, AND PARTICIPANTS This prespecified secondary analysis focused on HRQOL, a secondary outcome of the Daily Rest, Eating, and Activity Monitoring (DREAM) randomized crossover trial of children who underwent alternating weeks of sleep restriction and sleep extension and a 1-week washout in between. The DREAM trial intervention was administered at participants' homes between October 2018 and March 2020. Participants were 100 children aged 8 to 12 years who lived in Dunedin, New Zealand; had no underlying medical conditions; and had parent- or guardian-reported normal sleep (8-11 hours/night). Data were analyzed between July 4 and September 1, 2022. INTERVENTIONS Bedtimes were manipulated to be 1 hour later (sleep restriction) and 1 hour earlier (sleep extension) than usual for 1 week each. Wake times were unchanged. MAIN OUTCOMES AND MEASURES All outcome measures were assessed during both intervention weeks. Sleep timing and duration were assessed using 7-night actigraphy. Children and parents rated the child's sleep disturbances (night) and impairment (day) using the 8-item Pediatric Sleep Disturbance and 8-item Sleep-Related Impairment scales of the Patient-Reported Outcomes Measurement Information System questionnaire. Child-reported HRQOL was assessed using the 27-item KIDSCREEN questionnaire with 5 subscale scores and a total score. Both questionnaires assessed the past 7 days at the end of each intervention week. Data were presented as mean differences and 95% CIs between the sleep restriction and extension weeks and were analyzed using intention to treat and an a priori difference in sleep of at least 30 minutes per night. RESULTS The final sample comprised 100 children (52 girls [52%]; mean [SD] age, 10.3 [1.4] years). During the sleep restriction week, children went to sleep 64 (95% CI, 58-70) minutes later, and sleep offset (wake time) was 18 (95% CI, 13-24) minutes later, meaning that children received 39 (95% CI, 32-46) minutes less of total sleep per night compared with the sleep extension week in which the total sleep time was 71 (95% CI, 64-78) minutes less in the per-protocol sample analysis. Both parents and children reported significantly less sleep disturbance at night but greater sleep impairment during the day with sleep restriction. Significant standardized reductions in physical well-being (standardized mean difference [SMD], -0.28; 95% CI, -0.49 to -0.08), coping in a school environment (SMD, -0.26; 95% CI, -0.42 to -0.09), and total HRQOL score (SMD, -0.21; 95% CI, -0.34 to -0.08) were reported by children during sleep restriction, with an additional reduction in social and peer support (SMD, -0.24; 95% CI, -0.47 to -0.01) in the per-protocol sample analysis. CONCLUSIONS AND RELEVANCE Results of this secondary analysis of the DREAM trial indicated that even 39 minutes less of sleep per night for 1 week significantly reduced several facets of HRQOL in children. This finding shows that ensuring children receive sufficient good-quality sleep is an important child health issue. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry: ACTRN12618001671257.
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Improving perinatal sleep via a scalable cognitive behavioural intervention: findings from a randomised controlled trial from pregnancy to 2 years postpartum.
Bei, B, Pinnington, DM, Quin, N, Shen, L, Blumfield, M, Wiley, JF, Drummond, SPA, Newman, LK, Manber, R
Psychological medicine. 2023;53(2):513-523
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Sleep disturbance is a universal experience during the pregnancy and postpartum periods. Sleep disturbance is linked to a range of negative consequences. Literature shows that cognitive behavioural Therapy for Insomnia (CBT-I) is an effective treatment, with comparable short-term and superior long-term effects to sleep medication alone. The aim of this study was to evaluate the short-, medium-, and long-term efficacy of a non-pharmacological sleep intervention in the perinatal periods. The study was a longitudinal randomised controlled trial based on the SEED (Sleep Eat Emotions and Development) project which was a two-arm, parallel-group, single-blind, superiority randomised controlled trial. Participants were pregnant women enrolled in Childbirth Education and were randomised 1:1 to the intervention or a comparison condition. Results showed that compared to receiving an attention- and time-matched control, receiving a cognitive behavioural sleep intervention was associated with lower symptoms of insomnia, sleep disturbance, and sleep-related impairment during late pregnancy. Moreover, the intervention had long-term benefits to gestational parents’ sleep at 2-year postpartum. Authors conclude that a scalable cognitive behavioural sleep intervention, tailored for the perinatal periods, is feasible, acceptable, and efficacious in buffering against the natural increase in sleep complaints during the 3rd trimester.
Abstract
BACKGROUND Sleep disturbance is common in gestational parents during pregnancy and postpartum periods. This study evaluated the feasibility and efficacy of a scalable cognitive behavioural therapy (CBT) sleep intervention tailored for these periods. METHODS This is a two-arm, parallel-group, single-blind, superiority randomised controlled trial. Nulliparous females without severe medical/psychiatric conditions were randomised 1:1 to CBT or attention- and time-matched control. All participants received a 1 h telephone session and automated multimedia emails from the third trimester until 6 months postpartum. Outcomes were assessed with validated instruments at gestation weeks 30 (baseline) and 35 (pregnancy endpoint), and postpartum months 1.5, 3, 6 (postpartum endpoint), 12 and 24. RESULTS In total, 163 eligible participants (age M ± s.d. = 33.35 ± 3.42) were randomised. The CBT intervention was well accepted, with no reported adverse effect. Intention-to-treat analyses showed that compared to control, receiving CBT was associated with lower insomnia severity and sleep disturbance (two primary outcomes), and lower sleep-related impairment at the pregnancy endpoint (p values ⩽ 0.001), as well as at 24 months postpartum (p ranges 0.012-0.052). Group differences across the first postpartum year were non-significant. Participants with elevated insomnia symptoms at baseline benefitted substantially more from CBT (v. control), including having significantly lower insomnia symptoms throughout the first postpartum year. Group differences in symptoms of depression or anxiety were non-significant. CONCLUSIONS A scalable CBT sleep intervention is efficacious in buffering against sleep disturbance during pregnancy and benefitted sleep at 2-year postpartum, especially for individuals with insomnia symptoms during pregnancy. The intervention holds promise for implementation into routine perinatal care.
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Physical activity, inactivity and sleep during the Diabetes Remission Clinical Trial (DiRECT).
Cassidy, S, Trenell, M, Stefanetti, RJ, Charman, SJ, Barnes, AC, Brosnahan, N, McCombie, L, Thom, G, Peters, C, Zhyzhneuskaya, S, et al
Diabetic medicine : a journal of the British Diabetic Association. 2023;40(3):e15010
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Increasing physical activity is difficult for many individuals living with obesity and diabetes. Sustained, moderate activity is likely to be valuable for weight loss maintenance. The aim of this study was to explore whether randomisation to weight loss plus maintenance in the DiRECT trial was associated with physical activity, inactivity or sleep. DiRECT was a 2-year, open-label, cluster-randomised controlled trial conducted at 49 primary care (PC) practices. PC practices were randomised (1:1) to either an evidence-based weight management programme (Counterweight Plus; intervention) or best-practice care in accordance with guidelines (control). Results showed that: - repeated low-intensity advice to increase physical activity in the DiRECT intervention group did not produce change. - those people who had long-term weight loss success with the low-energy diet had positive changes in physical activity and inactivity. - wakefulness after sleep onset decreased in the intervention group. - weight loss ≥10% was associated with both increased physical activity and sleep quality. Authors conclude that it is important to optimise long-term weight loss maintenance by developing interventions encompassing restrained food intake, together with effective but affordable physical activity/inactivity strategies.
Abstract
AIMS: As sustained weight loss is vital for achieving remission of type 2 diabetes, we explored whether randomisation to weight loss plus maintenance in the DiRECT trial was associated with physical activity, inactivity or sleep. METHODS Participants were randomised to either a dietary weight management programme or best-practice care. The weight management group were encouraged to increase daily physical activity to their sustainable maximum. Objective measurement was achieved using a wrist-worn GENEActiv accelerometer for 7 days at baseline, 12 and 24 months in both groups. RESULTS Despite average weight loss of 10 kg at 12 months in the intervention (n = 66) group, there were no differences in total physical activity or inactivity compared with the control (n = 104) at any time point. However, in our exploratory analysis, those who lost more than 10% of their baseline body weight performed on average 11 mins/day more light activity than the <10% group at 24 months (p = 0.033) and had significantly lower bouts of Inactivity30min (interaction, p = 0.005) across 12 and 24 months. At 24 months, the ≥10% group had higher daily acceleration (38.5 ± 12.1 vs. 33.2 ± 11.1 mg, p = 0.020), and higher accelerations in the most active 5-hour period (59.4 ± 21.8 vs. 50.6 ± 18.3 mg, p = 0.023). Wakefulness after sleep onset decreased in the intervention group compared with the control group and also in the ≥10% weight loss group at 12 and 24 months. CONCLUSIONS Randomisation to a successful intensive weight loss intervention, including regular physical activity encouragement, was not associated with increased physical activity although sleep parameters improved. Physical activity was greater, and night-time waking reduced in those who maintained >10% weight loss at 12 and 24 months. TRIAL REGISTRATION ISRCTN03267836.
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Does providing feedback and guidance on sleep perceptions using sleep wearables improve insomnia? Findings from "Novel Insomnia Treatment Experiment": a randomized controlled trial.
Spina, MA, Andrillon, T, Quin, N, Wiley, JF, Rajaratnam, SMW, Bei, B
Sleep. 2023;46(9)
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Insomnia involves difficulties with initiating sleep, maintaining sleep and early morning awakenings. Sleep–wake state discrepancy is a common phenomenon observed in 9%–50% of individuals with insomnia. In fact, sleep–wake state discrepancy is important to explore as it is linked to daytime functioning, self-reported happiness, social support and self-reported sleep. The primary aim of this study was to examine whether providing individuals with insomnia feedback about sleep using wearable devices, along with support for appropriate interpretation of sleep–wake state discrepancy, improves symptoms of insomnia as the primary outcome. This study was a two-arm, parallel-group, single-blind, superiority randomised controlled trial. Eligible participants were randomised 1:1 to intervention or control groups. Results showed that the intervention group had lower insomnia symptom severity and sleep disturbance and lower rates of insomnia disorder. However, the two groups did not meaningfully differ on all other secondary and exploratory outcomes at post-intervention. Authors conclude that addressing sleep–wake state discrepancy by providing education and guidance on wearable measured sleep data could reduce symptoms of insomnia. Additionally, future studies need to examine how sleep–wake state discrepancy guidance using wearable devices could supplement cognitive behavioural therapy for insomnia (CBT-I), and whether this addition could enhance the benefits of CBT-I.
Abstract
STUDY OBJECTIVES Insomnia is a disorder diagnosed based on self-reported sleep complaints. Differences between self-reported and sensor-based sleep parameters (sleep-wake state discrepancy) are common but not well-understood in individuals with insomnia. This two-arm, parallel-group, single-blind, superiority randomized-controlled trial examined whether monitoring sleep using wearable devices and providing support for interpretation of sensor-based sleep data improved insomnia symptoms or impacted sleep-wake state discrepancy. METHODS A total of 113 (age M = 47.53; SD = 14.37, 64.9% female) individuals with significant insomnia symptoms (Insomnia Severity Index(ISI) ≥10) from the community were randomized 1:1 (permuted block randomization) to receive 5 weeks (1) Intervention (n = 57): feedback about sensor-based sleep (Fitbit and EEG headband) with guidance for data interpretation and ongoing monitoring, and (2) Control (n = 56): sleep education and hygiene. Both groups received one individual session and two check-in calls. The ISI (primary outcome), sleep disturbance (SDis), sleep-related impairment (SRI), depression, and anxiety were assessed at baseline and post-intervention. RESULTS In total, 103 (91.2%) participants completed the study. Intention-to-treat multiple regression with multiple imputations showed that after controlling for baseline values, compared to the Control group (n = 51), the Intervention group (n = 52) had lower ISI (p = .011, d = 0.51) and SDis (p = .036, d = 0.42) post-intervention, but differences in SRI, depression, anxiety, and sleep-wake state discrepancy parameters (total sleep time, sleep onset latency, and wake after sleep onset) were not meaningful (P-values >.40). CONCLUSIONS Providing feedback and guidance about sensor-based sleep parameters reduced insomnia severity and sleep disturbance but did not alter sleep-wake state discrepancy in individuals with insomnia more than sleep hygiene and education. The role of sleep wearable devices among individuals with insomnia requires further research. CLINICAL TRIAL REGISTRATION The Novel Insomnia Treatment Experiment (NITE): the effectiveness of incorporating appropriate guidance for sleep wearables in users with insomnia. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378452, Australia New Zealand Clinical Trials Registry: ACTRN12619001636145.
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Treatment of obstructive sleep apnea in high risk pregnancy: a multicenter randomized controlled trial.
Tantrakul, V, Ingsathit, A, Liamsombut, S, Rattanasiri, S, Kittivoravitkul, P, Imsom-Somboon, N, Lertpongpiroon, S, Jantarasaengaram, S, Somchit, W, Suwansathit, W, et al
Respiratory research. 2023;24(1):171
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Preeclampsia is a leading cause of maternal and foetal morbidity and mortality. Obstructive sleep apnoea (OSA) during pregnancy has been identified as a risk factor for preeclampsia and gestational hypertension. Although continuous positive airway pressure (CPAP) is a standard treatment for OSA in the general population, there is limited data regarding the efficacy and safety of CPAP treatment during pregnancy. The aim of this study was to evaluate the efficacy of CPAP treatment in high-risk pregnancy with mild-to-moderate OSA in reducing BP and hypertensive disorders in pregnancy. This study was a multicentre, open-label, parallel-group randomised controlled trial. Pregnant women attending antenatal care at all collaborating hospitals were recruited. Results showed that CPAP significantly reduced blood pressure (BP), with larger effects on diastolic BP and mean arterial pressure than systolic BP. Furthermore, it reduced the incidence of preeclampsia and hypertensive disorders in pregnancy. Authors conclude that their findings raise the need for early diagnosis and treatment of OSA in high-risk pregnancies.
Abstract
BACKGROUND Obstructive sleep apnea (OSA) during pregnancy is a risk factor for preeclampsia possibly through a link to placental physiology. This study evaluates the efficacy of continuous positive airway pressure (CPAP) on the modulation of blood pressure and the reduction in preeclampsia in women with high-risk pregnancy and OSA. METHODS A multicenter open-label, randomized controlled trial comparing CPAP treatment versus usual antenatal care was conducted in three academic hospitals in Bangkok, Thailand. Participants included singleton pregnant women aged older than 18 years with any high-risk condition (i.e., chronic hypertension, obesity, history of preeclampsia or gestational diabetes in the previous pregnancy, or diabetes), and OSA (respiratory disturbance index 5-29.99 events/hour by polysomnography), who presented either in the first trimester (gestational age, GA 0-16 weeks) or subsequently developed OSA during the 2nd trimester (GA 24-28 weeks). The primary endpoint was blood pressure during antenatal care. Secondary endpoints included the incidence of preeclampsia. An intention-to-treat analysis was performed with additional per-protocol and counterfactual analyses for handling of nonadherence. RESULTS Of 340 participants, 96.5% were recruited during the first trimester. Thirty participants were later excluded leaving 153 and 157 participants in the CPAP and usual-care groups for the modified-intention-to-treat analysis. CPAP adherence rate was 32.7% with average use of 2.5 h/night. Overall, CPAP treatment significantly lowered diastolic blood pressure (DBP) by - 2.2 mmHg [95% CI (- 3.9, - 0.4), p = 0.014], representing approximately - 0.5 mmHg per hour of CPAP use [95%CI (- 0.89, - 0.10), p = 0.013]. CPAP treatment also altered the blood pressure trajectory by continuously lowering DBP throughout pregnancy with mean differences (95% CI) of - 3.09 (- 5.34, - 0.93), - 3.49 (- 5.67, - 1.31) and - 3.03 (- 5.20, - 0.85) mmHg at GA 18-20, 24-28, and 32-34 weeks, respectively compared to 0-16 weeks. Preeclampsia rate was 13.1% (20/153 participants) in the CPAP and 22.3% (35/157 participants) in the usual-care group with a risk difference (95% CI) of - 9% (- 18%, - 1%, p-value = 0.032) and a number-needed-to-treat (95% CI) of 11 (1, 21). CONCLUSIONS CPAP treatment in women with even mild-to-moderate OSA and high-risk pregnancy demonstrated reductions in both DBP and the incidence of preeclampsia. CPAP treatment also demonstrated a sustained reduction in DBP throughout gestation. Trial registration ClinicalTrial.GovNCT03356106, retrospectively registered November 29, 2017.