Clinical Research Directory

Collaborative Care Intervention for Cancer Patients and Their Family Caregivers -LITE

To test the efficacy of a web-based stepped collaborative care intervention to reduce symptoms of depression, pain, and fatigue and improve health-related quality of life (HRQL) in advanced cancer patients and to reduce stress and depression, and fewer CVD risk factors in caregivers.

Circadian Rhythms and Homeostatic Sleep Drive and Their Effect on Reward and Cognitive Control Systems in Adolescents

Adolescence is a time of heightened reward sensitivity and greater impulsivity. On top of this, many teenagers experience chronic sleep deprivation and misalignment of their circadian rhythms due to biological shifts in their sleep/wake patterns paired with early school start times, which may increase the risk for substance use (SU). However, what impact circadian rhythm and sleep disruption either together or independently have on the neuronal circuitry that controls reward and cognition, or if there are interventions that might help to modify these disruptions is unknown. Project 1 (P1), specifically examines homeostatic and circadian characteristics as mechanisms linking habitual sleep patterns, reward and cognitive control (at subjective, behavioral, and circuit levels), and longitudinal substance use risk.

Improving Sleep Health Outcomes for Family Caregivers

This pilot study is intended to evaluate the feasibility, acceptability, and preliminary efficacy of an adapted sleep health intervention for family caregivers. The researchers are piloting a randomized clinical trial to test the Family Caregiver Transdiagnostic Intervention for Sleep and Circadian Dysfunction (Caregiver TranS-C), a tailored intervention that integrates cognitive behavioral therapy, mindfulness, and caregiving guidance. The caregiving-tailored adaptation of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) has the potential to improve sleep health outcomes and enhance psychological well-being in family caregivers.

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. Brain imaging scans may be performed to look at brain function.

Effect of Early Parent Education on Children's Sleep

The goal of this clinical trial is to learn if providing sleep information and advice to expecting parents can increase sleep duration and decrease sleep problems in infants. The main questions it aims to answer is: * Does providing sleep information and advice to parents after birth enhance baby's total sleep duration over the 24-months study? * Which study group has fewer sleep problems (bedtime resistance, night waking frequency and duration, difficulty with naps) over the 24-month period? Participants will: * Receive regularly scheduled sleep information and advice emails * Complete weekly surveys for the first 8 weeks after birth * Complete monthly online surveys up to 24 months Researchers will compare both intervention groups to a control group that received no information and advice to see if the information and advice had an impact on the child's sleep.

Perioperative Sleep Quality and Postoperative Pain Outcomes

This is a prospective, observational cohort study that will examine how sleep quality impacts postoperative pain and opioid consumption for pediatric patients. The investigators will administer a questionnaire preoperatively to determine which patients have poor or good sleep quality. They will then compare postoperative pain and opioid use between groups for two weeks following surgery. For a secondary aim, investigators will use electronic medication vials (eCAP) to monitor participants' medication use at home and compare to self-reporting.

Cannabis Effects on Sleep, Circadian Rhythms, and Light Sensitivity in Young Adults

The goal of this study is to learn how cannabis use and discontinuation affect sleep, circadian rhythms, and sensitivity to light. The main questions it aims to answer are: 1. Does cannabis use and discontinuation impact sleep drive? 2. Does cannabis use and discontinuation impact light sensitivity and circadian phase?

Development and Multicenter Validation of an AI-Based Remote Photoplethysmography (rPPG) Facial Scan for Multimodal Health Assessment

The goal of this observational study is to learn if a non-contact facial scan using artificial intelligence (AI) can be used to check health status in adults living in urban areas such as Jakarta. The facial scan uses a method called remote photoplethysmography (rPPG), which measures small changes in blood flow from the face using a camera. The main questions this study aims to answer are: 1. How close are the results from the facial scan to standard medical measurements, such as heart rate, breathing rate, blood pressure, and oxygen levels? 2. Can the facial scan estimate other health indicators, such as blood sugar, lipid profile, HbA1c, and hemoglobin levels? 3. Is there a relationship between the facial scan results and mental health, such as stress, anxiety, and depression? Participants will take part in several simple and mostly non-invasive procedures: 1. Answer questionnaires about their mental health and daily habits 2. Have basic health checks, such as blood pressure, heart rate, and body measurements 3. Provide a blood sample for laboratory testing 4. Complete a facial scan using a camera for about 1 to 3 minutes Researchers will compare the results from the facial scan with standard clinical and laboratory tests to see how well the technology works. This study may help develop a simple and accessible screening tool that can be used for early detection of health risks. It may also support the use of digital health and telemedicine in community and clinical settings.

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

Sleep is essential to functional recovery in rehabilitation settings; however, sleep is likely to be disrupted during rehabilitation 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.

Cognitive Training for Student Sleep and Wellness

This randomized control trial (RCT) explores two potential stress reduction interventions: a digital mindfulness program personalized for first year college students and a problem-solving based stress management program. These interventions were chosen because they rely on evidence-based approaches to stress management: problem-solving for cognitive coping and mindfulness for attention monitoring and acceptance with a focus on concentration, clarity, and equanimity. This selection allows for the assessment of the comparative efficacy of these methods in addressing student stress and stress-related outcomes (sleep duration, mental health, and academic success). Personalization to the college student offers the potential for greater engagement and user satisfaction by tailoring the program while maintaining the empirically driven structure of a digital mindfulness program. The investigators predict greater engagement and satisfaction will lead to higher adherence, and thus more skill-building. In this small RCT, first year college students will complete one of the two intervention conditions: Equa and MyTime. This will allow for the exploration of the effects of personalized mindfulness training compared to an active control condition. This work has the potential for identifying effective, low-cost tools to help young adults manage their stress and stress-related health and may inform theory and future work on stress modification strategies for other populations. The main trials aims are: Specific Aim 1. To explore whether a personalized mindfulness intervention (Equa) leads to greater adherence, engagement and use satisfaction compared to a digital stress management program. Specific Aim 2. To explore whether a personalized mindfulness intervention leads to greater improvements in student stress and stress-related outcomes compared to a problem solving-based digital stress management program. Outcomes include perceived stress, depressive symptoms, nightly sleep duration, and grades.

Repurposing Low-Dose Clonidine for PTSD in Veterans

Hypothesis: Veterans with PTSD prescribed clonidine will demonstrate improvements in PTSD symptoms, including daytime, nighttime, and sleep-related behaviors.

Standardized Sleep Bundle for Cardiac Surgery Patients

The goal of this clinical trial is to evaluate the feasibility of using a standardized sleep bundle in adults undergoing cardiac surgery. The main questions it aims to answer are: 1. Can eligible participants be recruited and retained in the study? 2. Can participants follow the study procedures, including using sleep aids and completing daily assessments? 3. Can sleep and other clinical data be reliably collected during the hospital stay? Researchers will compare participants who receive the sleep bundle to participants who receive usual postoperative care. Participants will: * Use non-drug sleep aids, including a sleep mask, ear plugs, and a noise machine (sleep bundle group only). * Take sleep medications if needed, following a stepwise protocol (sleep bundle group only). * Complete daily sleep assessments using the Richards-Campbell Sleep Questionnaire (RCSQ). * Wear a Fitbit device at night to track sleep. * Follow usual postoperative care routines (control group) The study will also collect and describe data on sleep duration, nighttime awakenings, subjective sleep quality, incidence of postoperative delirium, and hospital length of stay to inform the design of a future larger trial.

Real-World Evidence in Patient-Reported Outcomes for Medical Cannabis (MC-RWE)

This prospective observational study aims to describe the effectiveness of MC on pain, epilepsy, sleep and /or anxiety/depression in a cohorts of patients authorized to use MC, using pre-defined, validated self assessment scales.

Saffron Extract Supplementation and Sleep Quality in Middle-Aged Adults

This randomized, triple-blind, placebo-controlled clinical trial aims to evaluate the effects of daily saffron extract supplementation (30 mg/day) for six weeks on objective and subjective sleep quality in middle-aged adults with mild-to-moderate sleep disturbances. Secondary outcomes include heart rate variability, cognitive processing speed, emotional state, perceived health status, and biochemical stress markers.

Differences in Rest, Emotion, and Arousal Modulation in Youth

The goal of this study is to examine the relationship between sensory responsivity, bedtime arousal levels, sleep disturbances, and daytime emotion dysregulation for autistic children (ages 6-10). In a subset of children with elevated sensory responsivity, a sensory-based bedtime manipulation targeting bedtime arousal levels will be tested.

Relationship Between the Severity of Sleep Deprivation in the First 48 Hours Postpartum, Breastfeeding Motivation, and Breastfeeding Success

The postpartum period is a critical time marked by significant physiological and psychosocial changes that can affect sleep, emotional well-being, and breastfeeding behaviors. Previous studies indicate that mode of delivery and sleep quality are closely associated with breastfeeding outcomes, with cesarean birth often linked to poorer sleep and lower breastfeeding success. Evidence also suggests that postpartum sleep disturbances are related to reduced breastfeeding self-efficacy, lower motivation, fatigue, depressive symptoms, and shorter breastfeeding duration. However, the literature lacks studies that evaluate insomnia severity, breastfeeding motivation, and breastfeeding success simultaneously-particularly during the first 48 hours after birth. This analytical study aims to assess insomnia severity, breastfeeding motivation, and breastfeeding success (LATCH) within the first 48 postpartum hours and to examine the relationships among these variables. Findings are expected to support early postpartum clinical interventions to improve maternal and infant health outcomes.

Impact of Sleep Restriction on Blood Pressure Reactivity

The purpose of the research study is to examine the effects of shortened sleep on blood pressure.

Sleep Survey for Medical Trainees

Background This is a survey to understand sleep in the context of medical trainees (on call) and the participants knowledge about the relevance of sleep, shiftwork, and the impact that sleep may have on their working performance. The survey has been developed by sleep experts from America, Europe, and Africa, in collaboration with the World Sleep Society. It should take about 30-40 minutes to complete. The survey will focus on three different aspects, complemented by two standard questionnaires: 1. Demographics and Place of Work 2. Basic Knowledge and Perception of Sleep 3. Sleep Routine 4. Epworth Sleepiness Scale, Insomnia Sleep Inventory

The Use of Multiple Sensors to Track Sleep in Nightshift Workers

Sleep is often a challenge for nightshift workers because their work and sleep schedules are inverted. Sleep is commonly measured using actigraphy, which is the standard measure of objective sleep in the general population; however, this method has substantial limitations for nightshift workers because the standard legacy algorithms only correctly identify 50.3% of daytime sleep. This significantly reduces the validity for nightshift workers. The purpose of this study is to test a novel method to expand actigraphy by using 1) a multi-sensor approach that 2) uses machine learning (ML) algorithms to increase the accuracy of detecting daytime sleep.

Overnight TI in TLE

The goal of this clinical trial is to gauge whether overnight, non-invasive temporal interference (TI) stimulation aimed at the hippocampus can reduce abnormal brain activity linked to seizures and improve sleep in adults with drug-resistant temporal lobe epilepsy. The main questions are: Does overnight TI stimulation lower seizure-related EEG activity during sleep? Does overnight TI stimulation improve sleep quality and sleep patterns measured overnight in the lab? Researchers will compare each participant's nights without stimulation to nights with active stimulation, and will also look at a night after stimulation ends to see whether any changes last. Participants will: Stay in-lab for six days for overnight sleep and EEG monitoring Have one night of monitoring without stimulation Receive TI stimulation during sleep for several nights Have another night of monitoring without stimulation after the stimulation nights Complete brief questionnaires and thinking/memory tasks before and after the stimulation nights Be checked for side effects and comfort during the study and at follow-up

MyVitalC: Sleep and Everyday Headache Management

Sleep disturbance and recurring headaches can negatively affect daily functioning, mood, and productivity. MyVitalC (ESS60 in extra virgin olive oil) is a commercially available dietary supplement that has generated anecdotal claims related to sleep quality and headache relief; however, human data remain limited. This real-world observational study is designed to help participants evaluate whether use of MyVitalC is associated with changes in sleep disturbance and headache frequency or severity in their own daily lives. Participants will complete a four-week baseline observation period without the intervention, followed by six weeks of daily MyVitalC use, with weekly self-reported assessments. Participants serve as their own control, allowing for within-person comparison of outcomes before and during product use.

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.

Light Exposure, Migraine Outcomes, and Sleep Quality

The purpose of this study is to examine the relationship between daily light exposure patterns, sleep quality, and migraine characteristics in adults with migraine, with and without photophobia, across an 8-week study period.

Effects of Probiotic Supplementation on Stress and Anxiety in Students

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.