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Sleep Problems clinical trials

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NCT ID: NCT06249217 Not yet recruiting - Sleep Hygiene Clinical Trials

Good Nights Sleep Program to Improve Child and Family Sleep

GNSP
Start date: February 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to pilot a randomized clinical trial designed to improve the sleep environments, sleep hygiene practices, and the duration and quality of sleep of children and parents in low-income families. It is hypothesized that child and parent sleep (assessed through subjective reports of sleep, sleep environments, sleep hygiene practices, and objective sleep data via sleep actigraphy collected with Fitbit watches) in the intervention group will improve between Week 2 (intervention session) and Week 4 (post-intervention session) as compared to child and parent sleep in the waitlist-control group.

NCT ID: NCT05072548 Recruiting - Sleep Problems Clinical Trials

The ABCs of SLEEPING: Effectiveness Study

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

This trial will examine the effectiveness of a mobile applicable intervention called the "ABCs of SLEEPING". This intervention provides parents with prioritized/customized sleep recommendations and a sleep report based on their responses to the "Sleep check-in". This app is evidence-based and developed by sleep researchers and its aim is to provide accessible evidence-based sleep information for parents of children aged 6 to 12 years of age.

NCT ID: NCT04633434 Completed - Stress Clinical Trials

Evaluation Study of Talk Parenting Skills

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

After development of the prototype Bedtime Routine module of the Talk Parenting program, the investigators will evaluate its feasibility and initial efficacy in a within-subjects pre-post design study. Through recruitment partner agencies, the investigators will recruit a sample of 52 at-risk families (52 primary parents, 52 target children). Primary parents will be assessed at enrollment via online an questionnaire, then provided an Amazon Echo Dot and asked to use the Bedtime Routine module for 4 weeks. They will then be re-assessed with the online questionnaire at 4 weeks (at treatment completion).

NCT ID: NCT04413188 Completed - Older People Clinical Trials

A Warm Foot Bath, Sleep Quality and Comfort Level

Start date: December 1, 2016
Phase: N/A
Study type: Interventional

Objectives: To determine the effectiveness of a warm foot bath on sleep quality and comfort level among elderly individuals with sleep problems. Design and methods: This study was a randomized controlled trial. A total of 217 elderly individual who stayed in two nursing homes. The sample consisted of 60 elderly individuals with sleep problem who were randomly assigned to either the warm foot bath group (n= 30) and control group (n=30).The study was completed with 60 elderly individuals. The primary outcome was an information questionnaire, the Pittsburgh Sleep Quality Index, the General Comfort Questionnaire and the Numerical Rating Scale.

NCT ID: NCT02670694 Completed - Clinical trials for Prader-Willi Syndrome

Sleep Abnormalities in Rare Genetic Disorders: AS, RTT, and PW

RDCRN
Start date: June 2011
Phase: N/A
Study type: Observational

This study will investigate sleep behavior in subjects with Angelman Syndrome, Rett Syndrome or Prader-Willi Syndrome. The study will also investigate sleep behavior in healthy siblings of subjects with Angelman Syndrome, Rett Syndrome or Prader-Willi Syndrome. These individuals will serve as control subjects. The study will use questionnaires designed to identify sleep disorders and how they affect behavior and quality of life. The principal goals of this study are: 1. To see how common sleep disorders are in individuals with Angelman Syndrome, Rett Syndrome or Prader-Willi Syndrome; 2. To see how sleep disorders affect behavior in these individuals; 3. To see whether sleep disorders and related behavior problems improve or worsen with age; 4. To see how specific disease conditions relate to sleep disorders and how bad the sleep disorders are; 5. To develop new treatment options to improve quality of life and behavior issues; and 6. To evaluate current treatment options to improve sleep problems in these individuals.

NCT ID: NCT02374918 Completed - Concussion, Mild Clinical Trials

Bright Light Therapy for Treatment of Sleep Problems Following Mild Traumatic Brain Injury

Start date: December 2014
Phase: N/A
Study type: Interventional

The purpose of the research study is to understand the effectiveness of a six-week course of light exposure on cognitive functioning, mood, activity, and sleep in people that have suffered a head injury leading to a concussion.

NCT ID: NCT02370173 Completed - PTSD Clinical Trials

A Non-Pharmacological Method for Enhancing Sleep in PTSD

Start date: September 2014
Phase: N/A
Study type: Interventional

Sleep disturbance is nearly ubiquitous among individuals suffering from PTSD and is a major problem among service members returning from combat deployments. The proposed study aims to test a novel, inexpensive, and easy to use approach to improving sleep among service members with PTSD. Primary outcome measures will include not only PTSD symptom improvement but also include neuroimaging of brain structure, function, connectivity, and neurochemistry changes. The proposal is firmly grounded in the emerging scientific literature regarding sleep, light exposure, brain function, anxiety, and resilience. Prior evidence suggests that bright light therapy is effective for improving mood and fatigue, and our pilot data further suggest that this treatment may be effective for improving daytime sleepiness and brain functioning in brain injured individuals. Thus, this intervention, in our own research and in the work of others, has been shown to affect critical sleep regulatory systems. Improving sleep may be a vital component of recovery in these service members. Our approach would directly address this issue. Our preliminary data have shown that this approach is extremely well tolerated and is effective for improving sleep, mood, cognitive performance, and brain function among individuals with brain injuries. Finally, the potential impact of this study is high because of the capability of transitioning the research to direct clinical application almost immediately. If the bright light treatment is demonstrated as effective, this approach would be readily available for nearly immediate large-scale implementation, as the devices have been widely used for years in other contexts, are already safety tested, and commercially available from several manufacturers for a very low cost. Thus, the impact of this research on treating PTSD would be high and immediate.

NCT ID: NCT01903681 Completed - Sleep Problems Clinical Trials

Assessment of the Pharmacokinetics of Circadin® in Children With Neurodevelopmental Disorders and Sleep Disturbances

Start date: March 2013
Phase: Phase 1
Study type: Interventional

There is increasing evidence that chronic sleep disorders in children with autism spectrum disorder (ASD), Angelman Syndrome (AS) and Smith-Magenis syndrome (SMS) are associated with disturbed melatonin secretion and melatonin administration has been shown to be effective in these populations. For children who have difficulties swallowing a tablet, Neurim has developed an age-appropriate Melatonin formulation in the form of mini-tablets which have the same dissolution profile as the Circadin® tablets product, thus should produce the same melatonin concentration-time profile with the same effects. This study concerns the pharmacokinetic study. The purpose of this study is to : - Establish the 24 hour baseline profile of endogenous saliva melatonin concentrations and urine 6-SMT excretion in children aged 2 up to and including 17 years with neurodevelopmental disorders with sleep disturbances. - Establish the concentration-time profile of saliva melatonin concentrations and 24 hour 6-SMT urine excretion after 2 and 10 mg Circadin® mini-tablets single dose administration in children aged 2 up to and including 17 years with neurodevelopmental disorders with sleep disturbances. - Evaluate the adverse event profile after a single dose of 2 or 10 mg Circadin® mini-tablets in children aged 2 up to and including 17 years with neurodevelopmental disorders with sleep disturbances.

NCT ID: NCT01764074 Completed - Bipolar Disorder Clinical Trials

Brief Sleep Intervention for Bipolar Disorder

Start date: January 2013
Phase: N/A
Study type: Interventional

Individuals with bipolar disorder (BD) experience extreme mood swings, or episodes of depression and (hypo)mania. These episodes are associated with poor functioning, worse course of illness, and high rates of suicidality. It is estimated that between 25 to 65% of individuals with BD attempt suicide and 4 to 19% of individuals with BD eventually die by suicide. Sleep disturbance has been identified as a primary prodromal as well as causal symptom of mood episodes and recently, has been found to be associated with higher rates of suicidal ideation and behavior. Given the role that sleep may have in mood stability and suicidality in BD, it seems imperative to further understand the association of sleep and suicide and how sleep interventions may be useful to reduce suicidality in BD. Thus, the primary aim of this study is to use an innovative home sleep monitoring device, or the Embla, to examine the association of sleep and suicidality in adult outpatients with BD. The Embla is unique in that it is a non-invasive device that can characterize sleep profiles by measuring the degree of sleep fragmentation and percentage of rapid eye movement (REM) sleep. The study duration is five to six weeks such that patients wear the Embla device for Week 1, participate in a brief sleep intervention for suicide during Weeks 2 and 3, and 4, and then wear the Embla device for one more week (Week 5). This intervention consists of three, 60-min sessions and utilizes cognitive-behavioral therapy strategies (e.g., psychoeducation, cognitive re-structuring, problem solving, behavioral activation) to improve sleep disturbance. The investigators expect that individuals at study entry with more sleep disturbance (as measured by the Embla) will report more suicidal ideation and behaviors. The investigators also hypothesize that from pre- to post-intervention, individuals will report less sleep disturbance as well as suicidal ideation and behaviors. Data from this research has immediate and practical implications for providers and their patients as it the first examination of sleep phenotypes and suicide in a high risk population as well as to explore the association of improvements in sleep with suicidality.

NCT ID: NCT01764035 Completed - Bipolar Disorder Clinical Trials

Mindfulness Therapy on Disrupted Sleep in Bipolar Disorder

Start date: February 2013
Phase: N/A
Study type: Interventional

The investigators propose to investigate the efficacy of a brief (4-session) Body Scan (BS) meditation intervention for individuals with bipolar I disorder with insomnia (i.e. difficulties falling or staying asleep). The investigators will compare the Body Scan intervention with a 4-session brief supportive psychotherapy (SP) intervention. The investigators hypothesize that the Body Scan will improve objective sleep quantity and quality.