Sleep Disorders
Featured Studies
Featured studies include only those currently recruiting participants. Studies with the most recent start date appear first.
The Role of mGluR5 in CBT-I
Study Type: INTERVENTIONAL
Start Date: August 1, 2025
Eligibility: 18 Years to , f
Location(s): Stony Brook University: Dept of Psychiatry, Stony Brook, New York, United States
This is mechanistic clinical trial that evaluates the role of one of the glutamate receptors (mGluR5) in cognitive behavioral therapy for insomnia (CBT-I) as a common pathway in improving sleep and depression.
Examination of the Dynamic Relationships of Sleep, Physical Activity, and Circadian Rhythmicity With Neurobehavioral Heterogeneity in ADHD
Study Type: INTERVENTIONAL
Start Date: June 17, 2025
Eligibility: 8 Years to 12 Years, t
Location(s): Kennedy Krieger Institute, Baltimore, Maryland, United States; Hugo W. Moser Research Institute at Kennedy Krieger, Baltimore, Maryland, United States
Attention deficit/hyperactivity disorder (ADHD) can present differently in individuals, with some individuals having difficulty with attentional control, hyperactivity, impulsivity, emotion dysregulation, and/or neurobehavioral functioning. The factors contributing to these different presentations remain unclear, but altered patterns of physical activity, sleep, and circadian rest/activity rhythms may play a key role.
The goal of this study is to leverage wearable technology (i.e., a wristband) to investigate the relationships between physical activity during the day, sleep patterns and disturbances, and 24-hour circadian rest/activity rhythms with differences in ADHD symptoms, emotion dysregulation, and related brain and behavioral features of attention-deficit/hyperactivity disorder (ADHD). The investigators hope this study will help improve assessment and intervention for individuals with ADHD by understanding how these factors relate to ADHD symptom expression and associated brain differences in ADHD.
Participants taking stimulant medication must withhold stimulant medication 24 hours before their research appointment and the morning of their research appointment. Stimulant medication may be restarted after the appointment is complete.
Participation in this study will require children to complete an initial 2-hour research appointment, two (2) weeks of activity and sleep monitoring at home using a wearable wristband and answering questions sent to a smartphone, and a second 4-hour research appointment after the 2-week period.
During the first research appointment, children will complete a cognitive assessment and a practice magnetic resonance imaging (MRI) scan. Parents/legal guardians will participate in the 30-45-minute sleep device training session with one of the research staff.
During the two weeks of activity/sleep monitoring at home, parents and children will answer questions about their sleep routine, ADHD symptoms, and emotional responding each morning and evening. Parents will be asked to install a questionnaire application on their smartphone. A prompt will be sent to their smartphone multiple times per day reminding parents to complete the brief assessment.
After the 2-week period, children will complete a 4-hour research appointment. During this research appointment, children will complete a 60-minute MRI scan and computer-based activities that assess cognitive skills, reward-based decision-making, and frustration tolerance. At the end of the research appointment, children will return the device to our research team. Parents may delete the questionnaire application from their phone at the end of the research appointment.
Participation will also require parents/legal guardians to complete questionnaires about their child. Questionnaires will be provided to the primary caregiver by email or at the beginning of their child's first research appointment. Parents agree to complete and return the questionnaires within one month of their child's research appointment.
Parents may be provided with additional questionnaires to give to their child's primary schoolteacher. This information is collected to better understand children's abilities, behavior, strengths, and weaknesses.
There are minimal risks associated with this study. Risks include fatigue, boredom, and mild discomfort.
There is no cost to participating in this study.
There is no direct benefit to participants for participating in this study.
Assessing Improvements in Mood and Sleep Trial
Study Type: INTERVENTIONAL
Start Date: May 20, 2025
Eligibility: 55 Years to , f
Location(s): The Regents of the University of California, Los Angeles, Los Angeles, California, United States; University of Pittsburgh, Pittsburgh, Pennsylvania, United States; Augusta University, Augusta, Georgia, United States
This is a multi-site randomized control trial involving people age 55+ years who have current depression symptoms plus another suicide risk indicator (either current suicidal ideation or a past history of attempt). Our goal is evaluate which of two different approaches works best to improve things like trouble sleeping, bad moods, and any suicidality.
Participants will complete diagnostic interviews, self-report scales, and wear an actigraphy device for the 8 weeks starting at the baseline visit.
Transdiagnostic Sleep and Circadian Intervention + Bright Light in Adolescents With Elevated Depression (TranS-C+BL)
Study Type: INTERVENTIONAL
Start Date: May 6, 2025
Eligibility: 12 Years to 18 Years, f
Location(s): Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania, United States; University of Pittsburgh, Pittsburgh, Pennsylvania, United States
The goal of this clinical trial is to adapt a sleep intervention for individuals representative of all demographic groups, including those who are at the highest risk for suicidal behavior. Sleep difficulties are a promising target for youth with suicidal thoughts and behavior to focus on as a prevention measure. We aim to increase intervention acceptability and impact by adapting it for the adolescent populations at highest risk for suicidal thoughts and behavior. The research project will compare Transdiagnostic Sleep and Circadian Intervention (TranS-C), an evidence based, modularized intervention that targets a range of sleep difficulties to a treatment as usual or control condition including providing weekly sleep feedback reports from data entered into a daily sleep diary and from wearing a sleep sensing, actigraphy watch. Participants in both conditions (TranS-C vs. Sleep Feedback) will wear an actigraphy sleep watch that monitors sleep, and complete daily sleep diaries via smartphone or email. Participants in the TranS-C condition will also wear bright light (BL) and blue blocking glasses each day as well as attend weekly or biweekly sessions with a Sleep Therapist. The sleep therapist will review sleep feedback during sessions.
Yoga Nidra for Insomnia and Posttraumatic Stress Symptoms
Study Type: INTERVENTIONAL
Start Date: March 3, 2025
Eligibility: 18 Years to 35 Years, f
Location(s): University College London, London, United Kingdom
This randomized feasibility study is designed to investigate the feasibility of recruitment and delivery of two variations (brief; full) of a virtual Integrative Restoration (iRest) yoga nidra meditation intervention in stressor- or trauma-exposed participants with insomnia and posttraumatic stress symptoms, compared to a waitlist control group. Feasibility will also be examined for data collection (daily sleep diaries and PTSD symptom surveys) and at-home polysomnography (PSG) study completion prior to and following the intervention. Feasibility measures will include study retention and-for the two yoga nidra groups-adherence to study protocol, and acceptability of the intervention will be assessed qualitatively, in semi-structured interviews, and quantitatively, with the Client Satisfaction Questionnaire, following the intervention. Acceptability of the daily surveys will also be assessed quantitatively.
Preliminary efficacy of the interventions on the primary treatment outcomes of insomnia and PTSD symptoms and symptom clusters will be assessed. Secondary outcomes include changes in specific sleep architecture assessed in an at-home polysomnogram (sleep stages, including stage N3 percentage, sleep spindles, rapid eye movement (REM) theta, total sleep time, wake after sleep onset time, sleep onset latency, sleep efficiency), daily sleep characteristics (total sleep time, sleep onset latency, wake after sleep onset time, sleep quality), daily PTSD symptoms, and mindfulness. Exploratory outcomes include sleep quality, experiential avoidance, emotion regulation, self-compassion, depression, anxiety, and nightmares.
Regulation of Emotion, Sleep Extension, and mTBI
Study Type: INTERVENTIONAL
Start Date: February 1, 2025
Eligibility: 18 Years to 35 Years, f
Location(s): Merrimack College, North Andover, Massachusetts, United States
Concussions are incredibly common, and often result in severe and long lasting symptoms, including, but not limited to, sleep deprivation and emotion dysregulation. This study aims to demonstrate the therapeutic benefits of sleep extension (napping) on emotion regulation in individuals after they sustain a concussion. Thus, sleep extension may be a cost-effective, low risk, supplemental treatment for those with emotion dysregulation following a concussion. The main questions it aims to answer are:
1. Is a nap an effective way to improve emotion regulation in individuals with a concussion? 2. Does a nap reduce the required executive resources necessary to regulate emotions in individuals with a concussion?
Sleep Promotion Program Primary Care
Study Type: INTERVENTIONAL
Start Date: December 13, 2024
Eligibility: 12 Years to 18 Years, f
Location(s): University of Pittsburgh, Pittsburgh, Pennsylvania, United States
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.
Sleep Mechanisms Of Regulating Emotions
Study Type: INTERVENTIONAL
Start Date: August 12, 2024
Eligibility: 25 Years to 60 Years, f
Location(s): Stanford University, Palo Alto, California, United States
This project is the second phase of a two-phased project investigating the impact of a proven sleep intervention, Cognitive Behavioral Therapy for Insomnia (CBT-I) on engagement of the emotion regulation brain network as a putative mechanistic target.
Better Sleep Study
Study Type: INTERVENTIONAL
Start Date: March 15, 2024
Eligibility: 12 Years to 18 Years, f
Location(s): UCSF Nancy Friend Pritzker Psychiatry Building, San Francisco, California, United States
The overall aim of this proposal is a confirmatory efficacy trial sufficiently powered and designed to test the hypothesis that improving the relationship between biological circadian timing and waketime, a novel modifiable target, improves depression outcomes in a subgroup of adolescents with depression and a misaligned relationship between biological circadian timing and waketime utilizing a cognitive-behavioral sleep intervention.
Optimizing Attention and Sleep Intervention Study
Study Type: INTERVENTIONAL
Start Date: December 1, 2023
Eligibility: 3 Years to 5 Years, f
Location(s): Children's Community Pediatrics Bass Wolfson, Squirrel Hill, Pittsburgh, Pennsylvania, United States; University of Pittsburgh, Pittsburgh, Pennsylvania, United States; Children's Community Pediatrics GIL East Liberty, Pittsburgh, Pennsylvania, United States; Children's Community Pediatrics Shenango, New Castle, Pennsylvania, United States; Children's Community Pediatrics GIL Murrysville, Monroeville, Pennsylvania, United States; Children's Community Pediatrics Bass Wolfson, Cranberry, Cranberry Township, Pennsylvania, United States
The goal of this pilot clinical effectiveness trial is to compare a brief parent behavioral intervention (PBI) to a modified sleep focused PBI (SF-PBI) delivered by therapists in pediatric primary care for families of children 3-5 years old with sleep problems and early ADHD symptoms.
The main aims are to:
Aim 1: Demonstrate the acceptability, feasibility, and appropriateness of the sleep focused PBI (SF-PBI) delivered in pediatric primary care for preschool-aged children (3-5 years old) at elevated risk for ADHD.
Aim 2: Examine change in target engagement (sleep) and ADHD symptoms among preschool-aged children at elevated risk for ADHD receiving SF-PBI compared to standard PBI.
NIMH Rhythms and Blues Study: A Prospective Natural History Study of Motor Activity, Mood States, and Bipolar Disorder
Study Type: OBSERVATIONAL
Start Date: November 3, 2023
Eligibility: 12 Years to 70 Years, t
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States
Background:
Mood disorders, such as bipolar disorder, can have serious effects on a person s life. People with bipolar disorder are more likely to have heart disease and abuse substances. In this natural history study, researchers would like to learn more about the connection between exercise and mental health in people with and without mood disorders.
Objective:
To better understand relationships among physical activity, sleep, and mental health.
Eligibility:
People aged 12 to 60 years with a history of a mood disorder. Healthy spouses and relatives with no mood disorders are also needed.
Design:
Participants will be in the study up to 2 years.
For up to 20 days in a row, at 4 times during the study, participants will:
Complete an electronic diary on their smartphone. Participants will answer questions about their mood, health, sleep, and daily activities.
Wear an activity monitor, like a wristwatch, that records how much they move.
Wear a light sensor, as a necklace, to record the amount of light in their environment.
Some participants will do additional tests. Twice during the study, for 3 days in a row, they will:
Wear monitors to record their temperature, heart rate, and sleep.
Provide saliva samples.
Complete cognitive tasks on their smartphone.
Participants will visit the NIH clinic 2 times. They will have a physical exam, with blood and urine tests. They will wear a heart monitor. They will ride a stationary bike for 30 minutes. They may have an imaging scan.
Some participants will stay overnight. They will go to sleep wearing a cap to measure their brain activity.
Human Learning of New Structured Information Across Time and Sleep
Study Type: INTERVENTIONAL
Start Date: June 5, 2023
Eligibility: 18 Years to 35 Years, t
Location(s): University of Pennsylvania, Philadelphia, Pennsylvania, United States
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.
Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders
Study Type: OBSERVATIONAL
Start Date: December 27, 2012
Eligibility: 1 Day to 99 Years, t
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States
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....
