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.

Wearable Sleep EEG and Auditory Stimulation in Healthy Adults

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.

Sleep Promotion Program Primary Care

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.

Relationships Among Pupil Responses to Light, Circadian Rhythms, and Sleep

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.

Circadian-Synchronized Breast Milk Feeding and Sleep in Preterm Infants: A Multicenter Randomized Controlled Trial

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.

Postoperative Pain After Pediatric Adenotonsillectomy With Ketorolac or Ibuprofen

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.

A Sleep Hygiene Intervention to Improve Sleep Health in Urban, Latino Middle School Children

The main goal of this study is to evaluate the "SIESTA" intervention, a culturally and contextually tailored sleep hygiene intervention that has the potential to exert greater improvements in sleep hygiene and sleep outcomes for group that may be more vulnerable to poor sleep health. The main question is: do SIESTA participants have improved sleep outcomes, sleep hygiene behaviors and less sleep-related impairment compared to Control Group participants? Participants randomized to the SIESTA intervention will: 1. Attend 4 remotely administered group sleep hygiene education sessions 2. Complete along with a parent/guardian, two individualized sessions administered by a SIESTA intervention facilitator 3. Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention. 4. Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality. Participants randomized to the Child Health Control condition will: 1. Attend 4 remotely administered group sessions covering general health topics 2. Complete along with a parent/guardian, two individualized sessions administered by a SIESTA intervention facilitator 3. Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention. 4. Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality. A secondary goal of the study is to conduct a process evaluation to prepare for future larger scale use of the intervention in other urban school settings. This will entail assessing Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) of the program through several methods, such as by conducting in-depth interviews with research participants and their parents/guardians, as well as school staff and by looking at rates of participation in the program.

Sleep-Assessment in Patients Between High Altitude HA vs. Sea Level LA in Healthy Individuals H

To study the effect of relocation from high altitude (Quito Ecuador: 2850m) to sea level on sleeping parameters by polygraphy in healthy individuals, who live permanently \>2600m.

Aerobic, Strength, Kegel (ASK) Exercise Intervention Perceptions for Postpartum Health

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.

Sleep-Assessment in Patients Between High Altitude HA vs. Sea Level LA in Patients With Pulmonary Arterial Hypertension PAH

To study the effect of relocation from high altitude (Quito Ecuador: 2850m) to sea level on sleeping parameters by polygraphy in patients with pulmonary arterial hypertension PAH, who live permanently \>2600m.

Does Wearing Compression Garments Affect Sleep in Soccer Players

This study investigated the effects of nocturnal compression garments on sleep quantity and quality in young elite male soccer players. Eighteen players participated in a randomized controlled crossover protocol conducted over four consecutive weeks. During the first week, participants completed a control condition without wearing compression garments. During the following three weeks, they completed three experimental conditions in randomized order: full compression leggings, compression calf sleeves, and non-compressive placebo garments. Each condition was performed for seven consecutive nights. Objective sleep parameters were assessed using actigraphy, while subjective sleep quality was evaluated using validated self-report measures. Training load, perceptual factors, pre-sleep nutrition, and nocturnal thermal conditions were monitored and controlled to limit potential confounding factors. The primary objective was to determine whether nocturnal compression garment use affects sleep quantity and quality in young elite soccer players.

Project REST: Regulation of Eating and Sleep Topography

Overweight/obesity and inadequate sleep are prevalent, and frequently co-occurring, health risks among children, both of which are associated with serious medical and psychosocial health complications including risk for cardiovascular disease. Although the investigator's data suggest that disrupted or shortened sleep may be causally associated with increased energy intake and weight gain in children, and with self-regulation and neural response to food cues in adults, understanding of mechanisms involved in the sleep/eating association is incomplete, thereby impeding development of targeted, optimally timed intervention strategies. The proposed mechanistic clinical trial aims to assess the effects of an experimental sleep manipulation on eating-related self-regulation and its neural substrates, and on real-world eating behavior, among children with overweight/obesity, which will help guide research efforts towards the refinement of prevention and intervention strategies targeting sleep and its eating-related correlates to curb weight gain throughout development.

Dexmedetomidine Trial for Effects on Rhythms, Sleep Architecture, and Biomarker Dynamics in Older Adults

The DEXTER study is a cross-over, double-blind, placebo-controlled pilot research study led by Dr. Peng Li. The goal of this project is to evaluate the safety, feasibility, and biological effects of a single dose of sublingual (under-the-tongue) dexmedetomidine (SL Dex) in older adults. Specifically, researchers want to see how this medication affects sleep patterns, internal 24-hour circadian rhythms, and the daily cycles of certain neurological proteins (specifically plasma p-tau217) associated with brain aging.

Multidimensional Sleep Health Intervention for Couples

The goal of this pilot dyadic study is to adapt a multidimensional sleep health (MDSH) intervention, previously disseminated at the individual level, for relationship partners, determine whether it improves sleep health and aspects of cardiometabolic health, and understand the role of dyadic dynamics in intervention effects. Can a dyadic MDSH intervention improve sleep health and blood pressure (primary outcomes) in relationship partners? Can a dyadic MDSH intervention improve anthropometric markers of adiposity, psychosocial indicators, stress, dyadic adjustment and coping, self-rated health (secondary outcomes) in relationship partners? As this is a single-arm study, there is no control group. All relationship partners will complete a three-tier screening process, attend two in-person visits to receive intervention materials, have blood pressure measured and sleep data collected using in-office and out-of-office monitors, participate in weekly check-in phone calls with research staff over the 8 weeks to support adherence and complete a voluntary follow-up phone call at 16 weeks to provide additional sleep health information. The multidimensional sleep health promotion intervention is based on evidence-based sleep hygiene education and established behavior change techniques and includes: report-back of sleep health profiles, S.M.A.R.T (specific, measurable, attainable, realistic, and timely) goal-setting and establishing a sleep health plan with a fixed sleep schedule, sleep health coaching and dyadic action planning, self-monitoring, virtual sleep hygiene education, motivational feedback, and addressing light and noise in the sleep environment. Mixed methods will be used to understand implementation metrics, processes, and outcomes to establish the successful completion and future expansion of the intervention within this context.

Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep

This study aims to determine whether, compared with placebo, the nighttime administration of a intravenous dexmedetomidine is effective at inducing sleep and preventing postoperative delirium in extubated post-cardiac surgical patients.

The First-Night Effect and Sex Differences in Strength and Muscular Endurance Performance

Introduction: The first-night effect, characterized by disturbed sleep in an unfamiliar environment, may impair next-day physical performance. However, whether this response differs between men and women remains unclear. This study investigated sex differences in the effects of sleeping in an unfamiliar environment on strength and muscular endurance in resistance-trained individuals. Methods: Thirty-two resistance-trained participants (16 women, 16 men; 23 ± 4 years) completed a randomized, counterbalanced crossover study involving two conditions: sleeping for 8 h at home or in the laboratory. The following morning, participants performed bench press and back squat strength tests across 25-90%1RM, followed by muscular endurance tests to failure at 65%1RM.

A Behavioural Sleep Intervention for People With Mild Cognitive Impairment and Mild Dementia

This is two arm pilot randomized controlled trial, with the intervention gorup receiving AI-supported behavioral sleep intervention and control group receiving usual care

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.

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.

Relieving Pain and Improving Sleep: Evaluating Topical Pain Relief and Sleep Patches

This minimal risk, randomized, double-blind, placebo controlled Institutional Review Board (IRB)-approved study with functional measurements, will evaluate pain relief and sleep improvement after use of a drug- free, non-invasive patch (FREEDOM or REM Patch; The Super Patch Company Inc.); using validated scales and functional measurement tools along with crossover and control groups within the same subject group not receiving an 'active' patch.

Human Learning of New Structured Information Across Time and Sleep

Acting adaptively requires quickly picking up on structure in the environment and storing the acquired knowledge for effective future use. Dominant theories of the hippocampus have focused on its ability to encode individual snapshots of experience, but the investigators and others have found evidence that it is also crucial for finding structure across experiences. The mechanisms of this essential form of learning have not been established. The investigators have developed a neural network model of the hippocampus instantiating the theory that one of its subfields can quickly encode structure using distributed representations, a powerful form of representation in which populations of neurons become responsive to multiple related features of the environment. The first aim of this project is to test predictions of this model using high resolution functional magnetic resonance imaging (fMRI) in paradigms requiring integration of information across experiences. The results will clarify fundamental mechanisms of how humans learn novel structure, adjudicating between existing models of this process, and informing further model development. There are also competing theories as to the eventual fate of new hippocampal representations. One view posits that during sleep, the hippocampus replays recent information to build longer-term distributed representations in neocortex. Another view claims that memories are directly and independently formed and consolidated within the hippocampus and neocortex. The second aim of this project is to test between these theories. The investigators will assess changes in hippocampal and cortical representations over time by re-scanning participants and tracking changes in memory at a one-week delay. Any observed changes in the brain and behavior across time, however, may be due to generic effects of time or to active processing during sleep. The third aim is thus to assess the specific causal contributions of sleep to the consolidation of structured information. The investigators will use real-time sleep electroencephalography to play sound cues to bias memory reactivation. The investigators expect that this work will clarify the anatomical substrates and, critically, the nature of the representations that support encoding and consolidation of novel structure in the environment.

Metabolic and Cognitive Parameters Following Partial Sleep Deprivation

The purpose of this study is to determine whether partial sleep deprivation, as compared with normal sleep, influences certain metabolic and cognitive parameters, related to food intake, hunger and memory functions, when participants are shielded from external time cues.

Pharmacokinetics of Melatonin Administered in Oral, Lotion, and Bubble Bath Formulations

Melatonin is a hormone that promotes sleep that is available without a prescription in the United States. In addition to oral supplements, melatonin can be purchased in the form of lotions and bubble baths with unknown dosage and no frequency or age recommendations. In this study, researchers will examine how quickly melatonin in lotion and bubble bath is absorbed compared to oral tablets, as well as how long the melatonin lasts in the body.

Night Owl Sleep Study: The Effect of Sleep on Fecal Microbiota

The goal of this clinical trial is to assess differences in the fecal microbiota and metabolome associated with insufficient and sufficient sleep, and to evaluate the response and recovery of the microbiota to changes in participant sleep profiles. Researchers will compare the effect of sleep intervention on both insufficient and sufficient sleepers to identify differences in fecal microbiota structure and function between cohorts during habitual sleep and during the sleep alteration intervention period.. Participants will be assigned to one of two cohorts based on their current sleep habits. Cohort 1 are participants who have insufficient sleep at baseline; this cohort will be assigned to spend 1.5 hours more in bed per night. Cohort 2 are participants who have sufficient sleep at baseline; this cohort will be assigned to spend 1.5 hours less in bed per night. The sleep intervention lasts for 14 days.