Sleep

Background: Poor sleep is common among refugee groups worldwide. It can lead to an increased risk of heart disease, diabetes, cancer, and premature death. It can also worsen mental health disorders. Researchers have studied the mental health issues among refugees from Bhutan in the United States. Now they want to understand more about how difficulty sleeping may relate to their other health outcomes. Objective: To learn how the social and environmental conditions Bhutanese refugees affect their sleep health and health outcomes. Eligibility: Refugees aged 18 years and older of Bhutanese-Nepali or Bhutanese American descent. The participants must live in central Ohio. Also needed are people aged 18 years and older who interact with Bhutanese refugees in this region. Design: Participants will participate in a focus group discussion. The group will have 8 to 10 participants. It will last 60 to 90 minutes. They will talk about their experiences as a refugee and their sleep health. Topics may include adjusting to a new culture; access to housing and health care; and experiences with differential treatment by members inside and outside of their group. The study team will audio record the discussion. They will not share the recording with anyone. Participants will complete a short questionnaire. They will answer questions about their age, sex, language preferences, and how long they have lived in the United States. Participants who are not refugees will take part in a virtual interview led by a member of the study team. Participants will share their experiences with adapting to a new culture, differential treatment, and other factors have affected refugees sleep. The interview will take about 1 hour.

Opioid use disorder (OUD) is a chronic relapsing disorder and is well-known for its high-risk rate of overdoses and death. In OUD, sleep and circadian disruptions are highly prevalent, interfere with opioid maintenance treatment outcomes and increase the risk of relapse. So far, commonly used pharmacological sleep treatments fail to improve sleep or decrease illicit drug use in OUD. Thus, there is an urgent need to fill this research gap. Previous work showed that OUD patients who were receiving opioid agonist treatment (MOUD+) exhibited greater irregularity of sleep-wake cycle. In OUD patients, sleep-wake irregularity was associated with years of heroin use and low light exposure. Bright light therapy (BLT) is a very promising circadian/sleep intervention for several sleep, psychiatric and neurological disorders. BLT improved circadian, sleep outcomes and negative mood. In a pilot study, BLT improved objective and subjective sleep in patients with alcohol use disorder. Here investigators proposed an intervention study for MOUD+ patients to determine effects of BLT as an adjunct treatment on sleep and circadian outcomes including endogenous circadian rhythm, rest-activity rhythm and sleep neurophysiology (Primary objectives); and to determine effects of BLT on brain function and on clinical outcomes including negative affect, craving and illicit drug use and whether changes in sleep and circadian rhythm mediate the BLT effect on brain recovery and clinical outcomes (Secondary objectives). Fifty MOUD+ will be assigned either to bright light or to dim light group for 2 weeks. The groups will be matched for age, sex, race and OUD medication (Methadone vs Buprenorphine). The study will run throughout the year such that it occurs during all seasons. Light exposure will be measured with light sensor for additional control. All MOUD+ participants will have a daily 30-min light exposure (bright or dim blue light) in the morning after their habitual wake-up time and will be asked to avoid evening light before bed. Dim light melatonin onset, accelerometer, sleep EEG and questionnaires will be used to measure objective and subjective sleep and circadian outcomes. For brain function, cue-reactivity task will be used to assess brain activation during drug craving. Resting state functional connectivity and brain state dynamics will be assessed by rsfMRI. Mood, opiate craving and illicit drug use will be assessed. All measures will be repeated before and after the treatment. Investigators expect that BLT would normalize sleep and circadian outcomes, attenuate impairments in brain functions and result in better clinical outcomes. If successful, light therapy will provide add-on benefits to opioid agonist therapy and facilitate OUD recovery process.

Patients frequently experience problems with sleep while admitted to the ICU. Good sleep is important in ensuring that your immune system responds properly to infection, for your heart to function optimally, and to support normal brain function such as memory. To address sleep problems in the ICU, a bundle of interventions to support more normal sleep are provided. These bundles consist of medications such as sedatives and environmental changes such as less frequent times being assessed overnight and noise reduction strategies. Although medications can make patients appear to be sleeping, most medications do not provide patients with restful sleep. More research is needed on medications that better mimick restful sleep. One such medication is dexmedetomidine. When formally measured dexmedetomidine can make sleep appear more like a patient sleeping at home as compared to the hospital. The purpose of this study is to test whether giving a patient in the intensive care unit dexmedetomidine helps have a more restful sleep and possibly be more alert and/or interactive the next day. To see if dexmedetomidine improves sleep, the investigators will compare the quality of sleep of two different groups of participants: one group that receives dexmedetomidine at night for 2 nights in a row and another group that does not. How well one sleeps will be measured, in either group, will be assessed by a portable sleep machine that is attached by several stickers. This study is called a pilot or feasibility study. A pilot study assesses how easy it is to recruit patients, whether the sleep machine is tolerated, and amount of time sleep is measured. It is anticipated that about 50 people will take part in this study. This study should take approximately 2 years to complete, and the results should be known in about 1-2 years thereafter.

What is this study about? This study will test a program called "Newenkantun" (which refers to a hand-strength game in Mapuche culture) designed to help young children develop important social and emotional skills through play and physical activity. The program focuses on helping children learn how to understand and manage their emotions, get along with others, and make good decisions - skills that are important for success in school and life. Why is this study being done? The early years of childhood are a critical time for developing social, emotional, and physical skills. Many children, especially those from low-income families, face challenges that make it harder to develop these skills. This study will test whether a program that combines active play, social-emotional learning, and family involvement can help young children in the Araucanía region of Chile develop these important abilities. The program also aims to help children be more physically active, spend less time on screens, and get better sleep - all of which are important for healthy development. Who can participate? Children ages 4-6 years old (attending transition levels 1 and 2 in early childhood education) in the cities of Temuco and Padre Las Casas in the Araucanía region of Chile. Both their teachers and parents/guardians will also participate in the program. What will participants do? Children will participate in play-based activities at their schools over 16 weeks. These activities use storytelling and imaginative play (like pretending to be different characters) to help them practice social and emotional skills. The activities respect and incorporate the cultural background of the Araucanía region, including Mapuche cultural elements. Teachers will receive training and support (both in-person and online) to learn how to teach social-emotional skills and promote healthy movement behaviors in their classrooms. They will receive materials and kits to help them run play activities. Parents and guardians will receive support through an online platform, app, social media, and printed materials. They will learn about the importance of social-emotional development and healthy movement habits, and get practical tips for supporting these at home. The program includes 8 topics delivered over 4 months, with each topic taking about 30 minutes to complete. What will be measured? Researchers will measure: Children's social and emotional skills (like managing emotions, getting along with others, and making responsible decisions) Physical activity levels, screen time, and sleep patterns Motor skills and thinking abilities Teachers' confidence and practices in teaching social-emotional skills Parents' support practices at home The school environment and how well it supports these skills These measurements will happen at the beginning of the program, at the end, and at follow-up visits 3, 6, and 12 months after the program ends. How is the study designed? The study uses a "stepped-wedge" design, which means that 10 schools will start the program at different times, chosen randomly. This design allows all schools to eventually receive the program while still allowing researchers to compare results. Each school will participate for 16 weeks, and researchers will follow what happens afterwards to see if the benefits last over time. What are the potential benefits? If successful, this program could provide a practical, culturally appropriate way to help young children develop important social, emotional, and physical skills during a critical time in their development. The program is designed to be sustainable and could potentially be used in other schools and communities in the future.

The purpose of the PeerScreen trial is to investigate whether reducing screen media use affects mental health, social interaction, sleep, physical activity, heart rate variability, and behavioral patterns in young people aged 13 to 24 years. The primary question the trial aims to answer is: Does reducing screen media use over a 4-week period improve mental health among young people? Researchers will compare a screen media reduction intervention with a control condition in which participants continue their usual screen media use to determine whether reducing screen media use leads to improvements in mental health. Participants will: * be allocated to either a 4-week screen media reduction intervention or a control condition * complete a study protocol including questionnaire-based assessments, daily self-reports, and objective monitoring of screen media use, sleep, physical activity, heart rate variability, social interactions, and geolocation

This study will evaluate a program called On Track for Wellness (OTW) which is being adopted by the Illinois Department of Human Services' Division of Behavioral Health \& Recovery (DBHR) for use in all state-funded early psychosis programs in Illinois. OTW combines use of Fitbit activity trackers with health education, goal setting to promote health activation, and ongoing support for maintaining healthy lifestyles. Successful completion of this research will gauge the effectiveness of this program in improving sleep hygiene and increasing physical activity among people recently diagnosed with schizophrenia or other psychotic disorders.

This clinical trial aims to find out whether a circadian-synchronized breast milk feeding approach can help improve sleep in preterm infants in the neonatal intensive care unit (NICU). The study mainly aims to answer the following questions: Can this feeding approach improve sleep in preterm infants? Can this feeding approach help preterm infants develop more regular sleep patterns compared with routine breast milk feeding? Researchers will compare a feeding approach that tries to match the time when breast milk was expressed with the time when the baby is fed, with routine breast milk feeding, to see whether this method can improve sleep in preterm infants. Participants will: Be randomly assigned to 1 of 2 groups: circadian-synchronized breast milk feeding or routine breast milk feeding. Receive the assigned feeding approach for at least 2 weeks during the study. Have one 12-hour continuous sleep monitoring session at 37 weeks of corrected age. Have changes in different sleep states recorded and analyzed during the study, so that sleep patterns can be compared between the 2 groups.

The goal of this clinical trial is to determine the effects of a 12-week sleep behavioral program for adults ages 25-65 with poor sleep and elevated cardiometabolic risk. The main questions it aims to answer are: To evaluate the feasibility of recruitment, enrollment, retention, and data collection; program fidelity; and participant engagement with coaching sessions, text messages, and weekly check-ins; and to assess preliminary pre-post program changes in participant self-reported sleep, sleep self-efficacy, action and coping constructs, and Brain Care Score. Participants will: Complete seven structured sleep coaching sessions by telephone; complete a brief weekly check-in questionnaire received by text message; and receive weekly automated one-way text messaging support.

The goal of this study is to examine whether an evening snack of 1 oz of walnuts consumed in place of usual evening snacks for 4 weeks has a beneficial effect on diet quality and sleep quality in adolescents age 13-17 years.

In South Africa, antiretroviral therapy (ART) has transformed HIV into a chronic, manageable condition, with high rates of viral suppression. As people living with HIV (PLWH) live longer, HIV care is increasingly focused on long-term health, quality of life, and prevention of non-communicable diseases such as obesity,cardiovascular disease, and metabolic disorders, which are increasingly common in this population. Sleep disturbance is highly prevalent among PLWH but is under-recognised in routine care. Poor sleep has been associated with adverse cardiometabolic, cognitive, and functional outcomes, yet is rarely systematically assessed in HIV programmes. Most existing evidence relies on subjective measures, with limited objective polysomnography data, particularly in African populations. In addition, the impact of different ART regimens on sleep health remains poorly understood. This study aims to evaluate and compare sleep health in virologically suppressed PLWH who switch from a dolutegravir-based regimen to a doravirine-based regimen versus thosewho remain on dolutegravir-based therapy. Sleep will be assessed using a multidimensional approach, incorporating polysomnography, actigraphy, and validated patient-reported outcome measures aligned with the RU-SATED framework. The study is particularly relevant in South Africa, where dolutegravir-based regimens are widely used and where obesity and metabolic disease are increasing. In a resource-limited setting where sleep disorders are often underdiagnosed, this study will generate locally relevant evidence on the relationship between ART and sleep health, with potential implications for more holistic HIV care.

Patients treated for breast cancer frequently complain of sleep disturbances, about 40% of them. Of the sleep disturbances experienced by patients, insomnia is the most common complaint. The prevalence of insomnia complaints is higher in breast cancer patients compared to other types of cancer, and is also higher than in the general population (between 20% and 70% in breast cancer patients vs 30% in the general population). A recent study indicates that sleep complaints concern 25% of patients even before diagnosis, and 46% (including 18% complaining of insomnia) at the time of diagnosis, showing the negative impact of the announcement of the pathology on the subjective quality of sleep, and particularly on symptoms suggestive of insomnia. However, objective information on a modification of sleep patterns in breast cancer remains scarce and does not allow us to conclude. In particular, previous studies have focused only on the effects of chemotherapy and have not always included a control group, limiting the significance of their results. The links with cognitive and psychopathological processes and the underlying mechanisms are not clearly demonstrated in this pathology. Finally, taking into account patients' complaints, it appears necessary to limit sleep disorders in breast cancer in order to improve patients' quality of life using non-medicinal and easy-to-implement approaches.

The goal of this clinical trial is to determine if asynchronous psychoeducational sleep intervention works to improve college students' levels of self-reported sleep health literacy, sleep quality, and executive functioning. The main questions it aims to answer are: Can an educational sleep intervention improve college students' sleep health literacy and sleep quality? Does improved sleep health literacy impact sleep quality? Does improved sleep improve executive functioning in a college student sample? The hypotheses of the present study include the following: * College students with poor sleep quality will have lower executive functioning * College students who participate in a brief educational sleep intervention will have more improvements in sleep health literacy compared to college students who do not * College students who participate in a brief educational sleep intervention will have more improvements in sleep quality compared to college students who do not * College students who participate in a brief educational sleep intervention will have more improvements in executive functioning compared to college students who do not. Researchers will compare the intervention group to a wait-list control group to see if college students who watch the psychoeducational sleep intervention have more improvements in sleep quality, sleep health literacy, and executive functioning than those who do not. Participants will: * Complete a pre-intervention survey * Respond to a post-intervention survey six weeks after the pre-intervention survey * Be randomly assigned to watch a 30-to 45-minute psychoeducational sleep lecture video either during the pre-intervention survey or after the post-intervention survey

This study investigates how acute exercise-induced muscular pain affects sleep quality and sleep architecture in people with insomnia compared to healthy sleepers. Sleep disturbances and pain often influence each other, creating a negative cycle; however, it remains unclear how acute muscle pain - such as delayed-onset muscle soreness (DOMS) after strenuous exercise - alters continuous sleep parameters and pain sensitivity differently in clinical insomnia populations versus healthy controls. Participants will be divided into two groups: individuals with clinical insomnia and age- and sex-matched healthy sleepers. Both groups will undergo a standardized exercise protocol designed to safely induce temporary, acute muscular soreness (DOMS). Objective sleep parameters (measured via wrist Actigraphy) and subjective sleep parameters (measured via sleep diaries), will be monitored before and after the pain induction. The primary goal is to determine whether individuals with insomnia experience greater sleep disruption and altered pain recovery trajectories following an acute painful event compared to healthy individuals.

This randomized, double-blind, placebo-controlled study evaluates the efficacy and safety of an 8-week probiotic supplementation (Lactobacillus plantarum LP140 and Bifidobacterium breve BB010 in total daily dose 1 × 10¹⁰ CFU or matching placebo) in reducing perceived stress and anxiety, and improvement related psychological parameters in healthy university students during the examination period. The primary outcome is the change in Perceived Stress Scale (PSS-10) score at week 5 and week 8 of interevention compared to placebo. The secondary outcomes are the changes in DASS-21 subscales (Stress, Anxiety, Depression), State-Trait Anxiety Inventory - State version scale (STAI-S), Sense of Coherence Scale (SOC-29), Pittsburgh Sleep Quality Index (PSQI), self-reported gastrointestinal symptoms (Likert scale) and incidence of adverse events during the 8-week lasting interventional study.

Perianesthesia (preoperative and postanesthesia care unit, PACU) nurses work rotating, often extended shifts that can disrupt sleep and increase fatigue, both of which are recognized threats to patient safety in high-acuity perioperative settings. Mindfulness, a trait-like capacity for present-moment, non-judgmental awareness, has been proposed as a psychological resource that may help nurses regulate attention and buffer the effects of sleep loss and fatigue on clinical performance. However, little is known about how sleep quality and quantity, shift-level fatigue, and mindfulness jointly relate to the day-to-day safety performance of perianesthesia nurses. This prospective, repeated-measures, single-center study examines the relationships among sleep, mindfulness, and shift-level safety performance among nurses working in the perianesthesia/PACU care areas of Ağrı Training and Research Hospital. Approximately 25 to 40 perianesthesia nurses will be followed across 8 to 12 of their own shifts each, with a target of 250 to 300 evaluable shift-level observations. At baseline, nurses will complete a demographic form together with the Pittsburgh Sleep Quality Index (B-PSQI) and the Mindful Attention Awareness Scale (MAAS). Before each observed shift, nurses will complete a brief pre-shift sleep and sleepiness diary; after each shift they will complete a post-shift acute-fatigue and shift-characteristics form. For each observed shift, trained researchers will use a researcher-developed Perianesthesia Safety Process Observation Form to document adherence to, and deviations from, applicable safety-critical care processes. The primary outcome is the Shift-Level Perianesthesia Safety Deviation Rate, defined as the number of observed safety-process deviations divided by the number of applicable safety processes for that shift. Secondary outcomes include post-shift acute fatigue, the occurrence of near-miss events, and exploratory analyses of whether trait mindfulness moderates the associations between sleep/fatigue and safety performance. No patients are directly enrolled as research subjects; only nurses and their shifts are observed. Findings are expected to inform strategies to support nurse sleep, wellbeing, and safety-critical performance in perianesthesia settings.

This is a 12-month, 2-arm randomized controlled trial (n=150) examining whether toddlers randomized at 12 months of age to 1.5 cup-equivalents/day of cow's milk-based dairy versus oat milk-based dairy, and followed to 24 months, have better growth, sleep, neurocognitive, and gut microbiome outcomes.

This study is a pre-post, open-label cohort study designed to investigate how a food-grade probiotic supplement affects biological measurements and wellbeing in healthy adults. Participants will take one capsule daily for either 1 month or 6 months. During the study, participants will complete online cognitive tasks and provide blood and stool samples collected during home visits by trained staff. The samples will be analysed to explore changes in gut bacteria and other biological markers. This study aims to understand whether the supplement is well tolerated and whether measurable biological changes occur. The study does not involve any experimental drugs or invasive procedures beyond blood sampling and stool collection, and participants will not be asked to change any current prescribed medications or treatments; with eligibility exclusions applying for recent antibiotics or immunosuppressants. The supplement is being studied for research purposes only and is not intended to diagnose, treat, or prevent disease. Participants will be invited to participate in a follow-up visit to assess long-term effects.

This study examines the efficacy of a mindfulness-based intervention designed to support pain and sleep management in adolescents and young adults with sickle cell disease. Participants will be assigned to either an intervention or usual care group. Participants who are assigned to the intervention group will use a smartphone-based mindfulness program that includes structured modules and guided mindfulness exercises over an approximately 8-week period.

The goal of this clinical trial is to examine how daily behavioral patterns in early pregnancy, including sleep, physical activity, and meal timing, influence continuous glucose dynamics and subsequent risk of gestational diabetes mellitus (GDM) in pregnant women without pre-existing diabetes. The main questions it aims to answer are: 1. Do early-pregnancy chronobehavioral patterns (e.g., irregular sleep, night eating, and unstable rest-activity rhythms) relate to continuous glucose patterns measured using continuous glucose monitoring (CGM)? 2. Can early behavioral and CGM-derived measures predict glucose regulation and metabolic outcomes later in pregnancy (24-28 weeks)? 3. Does real-time self-monitoring using wearable devices and food logging improve glycemic outcomes compared to usual care? This study is a prospective, nested randomized pilot trial embedded within the ongoing Towards Optimal Fertility, Fathering and Fatherhood studY (TOFFFY) cohort (NCT06293235) at KK Women's and Children's Hospital, Singapore. A total of 140 pregnant women without pre-existing diabetes, recruited at ≤13 weeks gestation, will be randomized in a 1:1 ratio to either a pilot arm (wearable-based self-monitoring) or a control arm (usual care). Participants in the pilot arm (n=70) will undergo intensive behavioral and metabolic monitoring over a 14-day period in early pregnancy, including continuous glucose monitoring using a CGM device, wrist actigraphy to assess sleep-wake and rest-activity patterns, and an AI-supported mobile application to record meal timing and dietary intake. Participants will have real-time access to their glucose data and behavioral feedback, enabling self-monitoring and potential behavioral adjustments.

Neurodevelopmental disorders (NDDs) in preschoolers are frequently accompanied by persistent sleep disturbances, such as delayed sleep onset and reduced sleep duration, which exacerbate behavioral problems, impair cognitive development, and increase parental stress. While behavioral parent education effectively improves sleep hygiene, access to in-person clinical programs remains limited by high parent dropout rates. Digital delivery offers a flexible, scalable alternative, yet randomized controlled trials (RCTs) evaluating both face-to-face and self-help mobile app formats specifically for preschoolers across NDDs remain scarce. This study is a three-arm RCT designed to evaluate and compare the efficacy of a parent-based sleep intervention delivered via face-to-face group sessions combined with usual care (UC) versus a digital self-help mobile application combined with UC, against UC alone in Hong Kong preschoolers with NDDs. The study also assesses downstream effects on child daytime behaviors, parental stress, and parent sleep/mood outcomes over a 12-month period.

The investigators are studying relationships among eye pathology, pupil responses to light, sleep, circadian rhythms, and hormones in healthy individuals and those with various medical disorders or illnesses. All participants will: * Answer questionnaires about their health * Receive an eye exam, * For one week at home, participants will track their sleep and wake using actigraphy (wrist worn wearable) and an online sleep diary. * Complete a pupillometry session (measuring pupil size in response to different lighting) at MGH Participants may also choose to participate in the following additional procedures in any order: * Within one week of their pupillometry session, an at-home saliva collection under dim light. Saliva melatonin can be analyzed to determine Dim-Light-Melatonin-Onset (DLMO), a marker of circadian timing. * If participants participate in one night saliva collection, a second night of at-home saliva collection with a bright light exposure to calculate melatonin suppression in response to light.

Investigators developed a brief, scalable, behavioral Sleep Promotion Program (SPP) for adolescents with short sleep duration and sleep-wake irregularity, which relies on two individual sessions and smart phone technology to deliver evidence-based strategies. This R34 will test the feasibility and initial effectiveness of the SPP program and provider training via pilot randomized controlled trial (RCT, n=50) comparing SPP to Sleep Psychoeducation, a brief session on healthy sleep habits. Participants will be adolescents (12-18 years) with short sleep duration, sleep-wake irregularity, and depression.

This prospective observational study will evaluate postoperative pain after outpatient pediatric adenotonsillectomy in adolescents prescribed either acetaminophen with ibuprofen or acetaminophen with oral ketorolac after discharge, based on the prescribing preference of the otolaryngology surgeon. Participants will complete text-message surveys after discharge to assess pain severity, medication administration, and functional recovery for up to 14 days.

The purpose of this single-site pilot study is to evaluate the feasibility, usability, and technical performance of a wearable sleep-monitoring system that records electroencephalography (EEG) and delivers brief, low-volume sounds during selected stages of sleep. Approximately 30 healthy adults aged 18 to 30 years will use the system at home for up to 12 weeks, with a target of at least 15 usable nights of sleep recording. Participants will also complete smartphone-based assessments of sleep, mood, stress, device experience, and memory. The study will evaluate home-use completion, EEG signal quality, automated sleep-stage detection, delivery of auditory stimulation, participant adherence, and safety and tolerability. This pilot study is intended to refine the device and study procedures and is not designed to determine whether the system treats depression or another medical condition.

The goal of this pilot clinical trial is to learn whether a 12-week home-based exercise programme is feasible, acceptable, and safe for postpartum women in Hong Kong who had hypertensive disorders of pregnancy. The exercise programme is called the Aerobic, Strength, and Kegel exercise programme, or ASK programme. The main questions this study aims to answer are: * Can postpartum women follow the ASK exercise programme at home? * Is the ASK exercise programme acceptable and safe? * Does the ASK exercise programme show early benefits for postpartum recovery and health? Researchers will compare women who receive the ASK exercise programme with women who receive standard postnatal care. Participants will be randomly assigned to one of the two groups. They will complete study assessments at the beginning of the study and after 12 weeks. Women in the ASK exercise programme group will complete three 60-minute exercise sessions per week for 12 weeks, supported by a mobile app and wearable device. Women in the standard postnatal care group will continue to receive usual postnatal care.