Clinical Research Directory

Stress, Coping, and Sleep Health Study

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.

MBSR and NLP, Postpartum Breastfeeding and Depression

The postnatal period is a risky period in which mothers experience regressive and progressive changes and rapid biopsychosocial changes. Since this process affects not only the mother but also the family, mothers are under intense stress due to adaptation to the changes that occur in this period.

Acupressure Therapy on Post-stroke Fatigue, Depression, and Sleep Disturbances in Ischemic Stroke Patients

Post-stroke fatigue (PSF) was defined as 'a subjective feeling of physical and/or mental exhaustion that is unrelated to exertion and does not typically improve with rest'. About 25\~85% of first stoke patients had PSF in the first year. Literature review from animal studies suggested the mechanism of post-stroke fatigue may be due to prolonged production of inflammatory cytokines process after stroke. Acupuncture therapy which regulates the inflammatory process may have the potential to ameliorate fatigue symptoms alone with sleep disturbance after stroke. Acupressure which stimulating the same acupoints by manually pressure may make it easy to perform in anytime and anywhere. The effect of circadian based acupressure application on post-stroke fatigue and sleep disturbances need be further examined. The purpose of this two-year study is to (1) explore the distribution of inflammatory cytokines (blood and urine IL-1β, IL-6, TNF-α, IL-8) and post-stroke fatigue and sleep, and (2) examine the effect of circadian-based acupressure application on the inflammatory cytokines (urine and blood IL-1β, IL-6, TNF-α, IL-8), and post-stroke symptoms fatigue and sleep) in ischemic stroke patients with post-stroke fatigue during rehabilitation. Ischemic stroke patients (N=240) will be assessed from the rehabilitation wards. Patients with fatigue (FAS\>=24) at assessment (n=78) will be further randomly assigned to the circadian based acupressure application group (AA), or the routine care control group (RC) for 2 weeks. Data of inflammatory cytokines (of IL-1β, IL-6, TNF-α, IL-8), post-stroke fatigue (Fatigue assessment scale), and sleep (Pittsburg Sleep Quality Index and consumer tracker) will be collected. Descriptive statistics, t-test, repeated measure ANOVA, linear/logistic regression or appropriate nonparametric equivalent will be used to compare pre-post differences and to compare differences between groups. Study results will provide information about the mechanism and effect of acupressure application on inflammation and post-stroke fatigue and sleep disturbances in ischemic stroke patients.

Capturing Parental Wellbeing in Everyday Life Through a Mobile Diary App

This observational study investigates the wellbeing of parents in German-speaking Switzerland in everyday contexts using smartphone-based Ecological Momentary Assessment (EMA). Family caregiving can be both rewarding and burdensome, yet little is known about how parental wellbeing fluctuates in daily life and across caregiving situations. The study aims to examine momentary subjective wellbeing, caregiving activities, and contextual factors in natural settings. Participants complete repeated real-time assessments via a digital diary application five times a day over a 14-day study period. The study seeks to characterize within-person variability in parental wellbeing and identify contextual factors associated with positive and negative daily experiences.

Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents

Sleep and circadian problems are associated with deleterious social, emotional, and cognitive outcomes, yet are modifiable. This prospective study will adapt and optimize an empirically supported behavioral intervention that addresses common sleep and circadian problems of autistic adolescents, who are at increased risk for mental health disorders, using a transdiagnostic approach. The knowledge gained from this study will help to address a critical need for accessible transdiagnostic sleep interventions for autistic adolescents, who experience a broad range of sleep and circadian problems at high rates and often lack access to specialty care treatment.

Heat and Mental Health - PART 2

The goal of this clinical trial is to learn how hot indoor temperatures affect mood in young adults with depression, with or without anxiety. It will also explore whether the time of day the heat happens matters, and whether changes in sleep, thinking, and daily activity help explain the effect. The main questions it aims to answer are: * Does heat during the day affect mood differently than heat at night? * Do changes in sleep, thinking, or activity help explain those effects? Researchers will compare a weekend that is hot during the day to a weekend that is hot at night to see how the timing of heat affects mood. Participants will take part for about four weeks. During that time, participants will: * Stay in a sleep lab for two weekends, two weeks apart. Each stay runs from Friday afternoon to Monday midday. * Spend one weekend in rooms that are hot (32°C, or 90°F) from 8 in the morning to 8 at night, and comfortable (22°C, or 72°F) overnight * Spend the other weekend in rooms that are comfortable (22°C, or 72°F) during the day and hot (32°C, or 90°F) overnight * Be woken up at 2 in the morning on the last night of each lab stay. Participants will answer questions and do short thinking tasks, then go back to sleep. * Wear sensors that track their sleep, heart rate, and body temperature, and swallow a small capsule that measures body temperature from the inside * Answer questions about their mood and do short thinking tasks, both in the lab and at home * Use a phone app for the whole four weeks of the study. The app asks about mood and sleep, and works with the sensors to track sleep, movement, heart rate, temperature, and humidity.

The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies

The overall purpose of this study is to understand the role of disrupted sleep in the association of exposure to early life adversity (adverse childhood experiences (ACEs)) with vascular endothelial (dys)function. In Aim 1 (The Iowa ACEs and Sleep Cohort Study), the investigators will utilize a cross-sectional cohort design with a state-of-the-art translational approach. Participants will be recruited to objectively characterize the degree to which lower sleep quality and quantity contribute to ACEs-related endothelial dysfunction, inflammation, and oxidative stress in young adults using: 1. rigorous at home sleep monitoring using 7-nights of wrist actigraphy and 2 nights of home-based polysomnography to objectively measure sleep quality (sleep efficiency, wakefulness after sleep onset and sleep depth), and total sleep duration, 2. in vivo assessment of endothelial function via flow-mediated dilation testing, and 3. in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells. This study to achieve this Aim. In Aim 2, approximately 70 eligible participants from Aim 1 (The Iowa ACEs and Sleep Cohort Study) will then be randomized to either a 6-week behavioral sleep intervention (cognitive behavioral therapy for insomnia) or a wait-list control to determine the mechanistic contribution of sleep disruption to vascular dysfunction in young adults with moderate-to-high exposure to adverse childhood experiences (ACEs). Following the intervention, participants will again complete: 1. rigorous at home sleep monitoring using 7-nights of wrist actigraphy and 2 nights of home-based polysomnography to objectively measure sleep quality (sleep efficiency, wakefulness after sleep onset and sleep depth), and total sleep duration, 2. in vivo assessment of endothelial function via flow-mediated dilation testing, and 3. in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells.

A Mobile App to Improve 24-Hour Movement Guideline Adherence in Preschoolers

The goal of this clinical trial is to evaluate whether a home-based mHealth intervention can improve adherence to the 24-Hour Movement Guidelines in preschool-aged children (3-4 years old) who currently meet 0 or 1 of the guidelines for physical activity, sedentary behavior, and sleep. The main questions it aims to answer are: * Can the intervention increase the proportion of children meeting all three 24-Hour Movement Guidelines (physical activity, screen-time, and sleep)? * Is the intervention feasible for parents to implement, as measured by a parent feedback survey? Researchers will compare an intervention group to a waitlist control group to assess whether the intervention leads to increased guideline adherence. Parents and Participants: * Children will wear an accelerometer to track physical activity and sleep patterns. * Parents will use a mobile app that delivers weekly lessons and behavior-related goals to encourage healthy movement behaviors in their children. * Parents will complete questionnaires on their child's movement behaviors and development at baseline, 6 weeks, and 12 weeks. * Additionally, children will undergo motor skills assessments, and parents will provide feedback on cognitive development and behavioral changes.

On Track for Wellness (OTW) Stepped Wedge Cluster Randomized Trial

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.

Stellate Ganglion Block on Postoperative Sleep Status in Patients With Prolonged Disorders of Consciousness

This is a prospective, single-centre, single-arm, self-controlled, exploratory pilot study. The goal of this clinical trial is to learn about the effect of preoperative administration of stellate ganglion block on postoperative sleep status in patients with prolonged disorders of consciousness. The main aims to answer are: To explore the feasibility and safety of unilateral SGB in pDOC patients, evaluate its impact on sleep time and sleep architecture from the preoperative night to the night of surgery, compare the cerebral hemodynamic parameters, cerebral oxygen saturation and Coma Recovery Scale-Revised (CRS-R) scores in pDOC patients before and after SGB, and inform the design and sample size calculation of a future definitive RCT. Participants will be pDoC patients with intact skulls after acquired brain injury who will undergo spinal cord electronic stimulator implantation under general anesthesia at Beijing Tiantan Hospital. Stellate ganglion block will be administrated before the surgery. Polysomnography, total sleep time, cerebral oxygen saturation, cerebral hemodynamic parameters, CRS-R scores will be investigated.

Sleep and Inflammatory Resolution Pathway

Goal of this project is to investigate whether increases in inflammation that result from common patterns of restricting sleep on week nights and catching up on sleep over the weekend are caused by disruption in the newly discovered inflammatory resolution pathways. These pathways are crucial in the active termination of the inflammatory response, and their disruption may contribute to ongoing unresolved inflammation, which has been observed not only during periods of sleep restriction, but also after recovery sleep has been obtained. If the hypothesis is true, it is possible that increasing the body's natural production of endogenous, inflammatory resolution mediators may provide a non-behavioral strategy to limit the inflammatory consequences in those undergoing periods of sleep restriction with intermittent recovery sleep.

Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders

Background: \- Many psychiatric, behavioral, and developmental disorders are genetic. This means that they tend to run in families. Some begin in childhood, while others do not appear until adulthood. Researchers want to look at people of all ages who have these disorders that started in childhood. They will also look at relatives of people with these disorders. This information will allow doctors to learn more about childhood behavioral problems and how they are inherited. It may also help doctors treat those disorders. Objectives: \- To study the onset and treatment of childhood behavioral, psychiatric, and developmental disorders. Eligibility: * Individuals of any age who have a psychiatric, autism spectrum, or developmental disorder, or other behavioral problems. * Family members of individuals with the above disorders. This group may include parents, grandparents, siblings, aunts/uncles, cousins, and children. Design: \- Participants will be screened with a medical history and physical exam. They may have a psychiatric history with tests of thinking, judgment, and behavior.

Circadian-informed Optimal Bedtime

The goal of this interventional study is to test whether circadian-informed bedtime recommendations can improve sleep, next-day psychomotor vigilance, and subjective well-being among healthy adults. The main questions it aims to answer are: * Can Optimal Bedtime derived from data collected by a consumer smartwatch increase the objective total sleep time? * Can Optimal Bedtime derived from data collected by a consumer smartwatch reduce the count of lapse in a next-day Psychomotor Vigilance Task? * Can Optimal Bedtime derived from data collected by a consumer smartwatch increase subjective sleep quality? Researchers will compare Optimal Bedtime with a placebo bedtime and an unguided baseline in a cross-over design. Participants will: * Be randomized 1:1 to either Optimal Bedtime then placebo or placebo then Optimal Bedtime. * Wear a consumer smartwatch for 6 weeks, 2 weeks in each of baseline, Optimal Bedtime, and placebo. * Complete a Psychomotor Vigilance Task and a subjective well-being survey every morning.

I-SLEPT: Integrated Sleep and Life Engagement Program for Transitions

Sleep is essential to functional recovery in inpatient medical settings; however, sleep is likely to be disrupted during rehabilitation and hospital admissions. Adverse effects of these disruptions do not subside after discharge, leading to additional consequences such as poor physical function. Veterans are particularly impacted by poor sleep and medical complexities that can lead to injuries requiring rehabilitative care to support their recovery. This may be more apparent in older Veteran populations. After discharge, Veterans must re-acclimate to their home environment while facing potential changes in their sleep, life engagement (e.g., pleasant activities, physical function), and health. This study will create the I-SLEPT (Integrated Sleep and Life Engagement Program for Transitions) intervention, which will support Veterans by stabilizing their sleep and by maximizing participation in meaningful activities during a critical and vulnerable period of recovery.

Effects of Root Extract Ashwagandha (KSM-66) on Perception of Recovery and Muscle Strength in Adolescents Aged 11 to 19 Engaged in Grassroots Football

This study will test whether six weeks of ashwagandha (KSM-66 root extract), helps teenage footballers recover and improve strength. Very little research has looked at young people aged 11 to 19, despite increased usage in this cohort. About 50 to 60 male and female players from grassroots clubs in Sussex, Surrey and Greater London will be randomly assigned to take a daily capsule of either 450 mg ashwagandha or a placebo in an unblinded fashion. Before and after the six weeks, players will do tests at their usual training site: saliva samples to measure the cortisol, grip strength, a 1 km time trial, and short questionnaires on recovery, sleep, stress and soreness. The results will show whether ashwagandha changes stress, strength, performance and perceived recovery over six weeks.

reALIGNing Circadian Rhythm and Promoting Sleep in the Intensive Care Unit

The goal of this pilot clinical trial is to learn whether a program to support sleep and the body's daily rhythms can be delivered safely and consistently to critically ill adults in intensive care units (ICUs). These rhythms help control when people feel awake or sleepy and can become disrupted during critical illness. The main questions it aims to answer are: Can enough participants be enrolled, and can ICU teams consistently deliver the program? Is the program acceptable to participants and care teams? What preliminary effects does the program have on sleep, daily rhythms, delirium (a sudden change in thinking that causes confusion), and recovery? Researchers will compare the sleep program with usual ICU care. Participants will be assigned by chance to one of these two groups. Findings will help researchers plan a larger trial. Participants will: Receive usual ICU care or the sleep program for 7 days, with treatment extended to up to 10 days when appropriate. If assigned to the sleep program, receive bright light in the morning, tube feeding at scheduled daytime and evening times, daily movement or exercise as their condition allows, and care that reduces unnecessary nighttime interruptions. Have sleep monitored using a portable recording device and undergo daily assessments for delirium. Answer questions about sleep and their experience of the study when able. Complete telephone assessments of memory, thinking, and sleep quality approximately 3 and 6 months after enrolment.

Effects of a School-Based Physical Activity Intervention on 24-Hour Movement Behaviours and Motor Development in Preschool Children - Study Protocol

This protocol describes a quasi-experimental controlled study evaluating the effects of the Super Quinas in Preschool programme on 24-hour movement behaviours and motor development in preschool children aged 3-6 years. The intervention consists of one additional structured 60-minute physical activity session per week for 12 weeks, delivered by a qualified exercise professional in a public preschool in Maia, Portugal. Four classes (\~80 children) are allocated at the class level: two to the intervention condition and two to the control condition (usual curricular Physical Education). Baseline data collection (T0) was conducted between 4 and 18 March 2026; the intervention commenced on 25 March 2026. Subsequent assessments are planned for early May (T1, mid-intervention), end of June (T2, post-intervention), and mid-September 2026 (T3, follow-up). Primary outcomes are 24-hour movement behaviours (ActiGraph GT3X accelerometry) and motor competence and physical fitness (Motor Competence Assessment + PREFIT subtests). Secondary outcomes include executive function (HTKS; Day-Night Stroop) and socioemotional regulation (SDQ). Statistical analyses will use longitudinal linear mixed-effects models under an intention-to-treat framework.

Prospective Longitudinal Study of Sleep, Brain Activity, and Plasma Analyses in Patients Undergoing Epilepsy Surgery

The goal of this observational study is to understand how sleep and brain activity change after epilepsy surgery in adults with drug-resistant epilepsy. Drug-resistant epilepsy means that seizures continue despite treatment with appropriate medications. The study will investigate whether changes in sleep and brain activity are related to seizure control, sleep quality, and quality of life after surgery. The main questions it aims to answer are: * How do sleep patterns and brain activity change after epilepsy surgery? * How are changes in sleep and brain activity related to seizure control and quality of life? * Do sleep patterns after surgery become more like those of healthy adults? * How are changes in blood proteins related to sleep, brain activity, and seizure control? Researchers will follow 30 adults undergoing epilepsy surgery. Their sleep will be compared with that of 10 healthy adults of similar age and sex. Healthy participants will complete the study assessments once. Participants undergoing epilepsy surgery will complete the assessments before surgery and approximately 2 and 6 months after surgery. At each assessment, participants will: * Wear a small device (actigraph) on their wrist for about 2 weeks to measure sleep and activity and keep a sleep diary. * Spend 2 consecutive nights at a patient hotel while their sleep and brain activity are recorded using polysomnography (PSG), a test that measures sleep, breathing, and brain activity. * Answer questionnaires about sleep quality, insomnia, mood, and quality of life. * Provide blood samples for research. Researchers will also collect information about seizure frequency, medications, and medical history. The sleep recordings will be used to study several aspects of sleep, including: * Sleep architecture: how much time participants spend in different stages of sleep and how often their sleep is interrupted. * Sleep spindles and slow oscillations: patterns of brain activity during sleep that are involved in how the brain processes and organizes information. * Cyclic alternating pattern (CAP): a measure of brief changes in brain activity during sleep that can provide information about sleep stability. * Epileptiform activity: abnormal electrical activity in the brain that may be associated with epilepsy and can occur during sleep. Researchers will also analyze proteins in blood samples to explore whether biological changes are related to sleep and seizure outcomes. Epilepsy surgery and other medical treatments will be decided by the participants' treating healthcare teams, independently of this study. The study will observe changes before and after surgery without assigning participants to a treatment.

Cross-sectional Study of Sleep Disturbance in Hong Kong Children With Cancer Comparing With Healthy Counterparts and Children With Other Chronic Diseases

Sleep disturbances are prevalent among children with chronic illnesses, yet the specific impact of cancer on sleep remains underexplored. This prospective and cross-sectional study aims to evaluate the prevalence, severity, and characteristics of sleep disturbances in Chinese children with cancer compared to healthy peers and children with other chronic diseases. By leveraging validated sleep assessment tools and parental reports, the goal is to identify unique challenges faced by children with cancer. Results might influence the design of personalized interventions aimed at enhancing the overall well-being of children with cancer. This study will enroll Chinese children aged 6 to 18 years, divided into three distinct groups based on their health status: children with cancer, children with other chronic illnesses, and healthy children. A total sample size of 150 participants (50 per group) will be targeted to ensure adequate statistical power for comparative analyses. Recruitment will occur at Hong Kong Children's Hospital or the cancer and chronic illness groups, and healthy children will be recruited from healthy siblings of participants or the healthy children of hospital staff with specific inclusion and exclusion criteria applied to each group to maintain homogeneity and minimize confounding variables.

HEARTBEAT SOUND FOR BREASTFEEDİNG DİFFİCULTİES: A RANDOMİZED CONTROLLED TRİAL

This randomized controlled trial aims to evaluate the effect of listening to a pre-recorded, standardized maternal heartbeat sound on perceived stress levels and breastfeeding self-efficacy in mothers experiencing early breastfeeding difficulties. The study will be conducted in the postpartum service of a tertiary hospital. The results are expected to contribute to easily applicable, non-invasive, and supportive care approaches for breastfeeding support.

Cannabis Association With Sleep Study

The purpose of this study is to learn more about cannabis use, sleep, and stress, and whether there is any relationship between the three.

Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years

Overweight and obesity, as well as periodontitis, are common public health problems with increasing prevalence. Both conditions may be linked through shared mechanisms involving chronic low-grade systemic inflammation. Numerous studies have reported an association between elevated body mass index (BMI) and periodontitis, particularly among younger and working-age populations. However, data regarding Thai adults under the age of 60 remain limited. Therefore, this study aims to determine the prevalence of high BMI and periodontitis among Thai adults aged 18-59 years and to identify factors associated with these conditions. The findings may provide useful information for improving awareness and supporting the prevention of both periodontal and general health problems in this population.

Effects of a Multi-Targeted Oral Supplement on Skin, Hair, Sleep, Energy, Cognition, Libido and Epigenetic Biological Clock Age

This study evaluated the effects of a daily oral supplement regimen (Advanced ID Brain, Heart and Eye Omega Gel Capsules taken with Advanced ID Longevity and Collagen Complex Powder) on measures of skin condition, hair, sleep, energy, cognition and sexual wellbeing in healthy adults aged 35 to 65 years. Participants were randomised in a 2:1 ratio to receive either the active supplement regimen or a matched placebo regimen once daily with food for 12 weeks. Instrumental skin measurements, trained-assessor visual grading and participant questionnaires were performed at baseline (Day 0), Day 28 and Day 84. Hair imaging and cognitive testing were performed at baseline and Day 84. Whole blood samples were collected at baseline and Day 84 for exploratory epigenetic DNA biological clock age analysis, reported separately. The study was single-centre, sponsored by IDI Skincare Limited and conducted by Eurofins Product Testing Services Ltd (trading as Eurofins Alba) in Edinburgh, United Kingdom.

Effect of Kava on Anxiety and Stress in Cancer Survivors

This is a pilot, two-arm, randomized, blinded, placebo-controlled cross-over clinical trial to study the safety and effect of 14 days of kava on anxiety and physiologic stress in survivors of cancer and its treatment. Participants will be randomized to take either kava first or placebo first. Kava 75 mg or placebo will be taken three time daily (TID) for 14 days (Period 1), followed by a washout period of 14-28 days. Thereafter, the participant will take either placebo or kava TID for 14 days (Period 2), whichever he/she did not take in Period 1.