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Insomnia Chronic clinical trials

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NCT ID: NCT06410495 Recruiting - Clinical trials for Oppositional Defiant Disorder

Digital Dyadic Family Based Intervention to Improve Sleep in Children With ODD and Their Parents: NiteCAPP SINCC (Pilot)

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

In this proposal a brief web-based cognitive behavioral treatment for insomnia (CBT-I) for children with oppositional defiant disorder (ODD) and their parents is iteratively adapted and tested for acceptability, feasibility, and preliminary efficacy.

NCT ID: NCT06350292 Recruiting - Clinical trials for Oppositional Defiant Disorder

SLEEP-COPE: Sleep Intervention for Oppositional Children

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Children with Oppositional Defiant Disorder (ODD) are at risk for insomnia, arousal dysfunction, mood problems, and noncompliance. Cognitive behavioral treatment for insomnia (CBT-I) holds promise for improving insomnia and related concerns. Telehealth delivery will reduce the burden of in-person sessions, particularly in areas where there is low mental healthcare access. Telehealth CBT-I is efficacious in adults and children but has not been tested in children with ODD. The proposed trial is the next logical step - development and iterative testing of SLEEP-COPE, a brief dyadic telehealth CBT-I for children with ODD and their parents.

NCT ID: NCT06281756 Recruiting - Insomnia Clinical Trials

Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia

Start date: March 14, 2024
Phase: Early Phase 1
Study type: Interventional

Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems.

NCT ID: NCT06053840 Recruiting - Insomnia Clinical Trials

An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia

RESTORE
Start date: September 21, 2023
Phase: Phase 4
Study type: Interventional

The primary aim of this Real-World Evidence trial is to establish whether short-term (2 weeks) treatment of Chloral Hydrate is effective in patients with severe insomnia which is interfering with normal daily life, and where other behavioural and pharmacologic therapies have failed in a real world setting.

NCT ID: NCT05875129 Recruiting - Cancer Clinical Trials

Device Feasibility and Acceptability to Improve Insomnia in Cancer

Start date: July 20, 2023
Phase: N/A
Study type: Interventional

Sleep disruption is common among young adult cancer survivors for a variety of reasons. Cognitive behavioral therapy for insomnia (CBT-I) has been shown to improve chronic sleep disorders. This project will test the feasibility and acceptability of a new voice-activated virtual assistant (VAVA) device to deliver CBT-I to improve sleep among young adult cancer survivors with chronic sleep disorders.

NCT ID: NCT05797324 Recruiting - Insomnia Chronic Clinical Trials

Light Therapy in Modulating the Clinical Phenotype of Patients With Primary and Comorbid Chronic Insomnia.

Luminoterapia
Start date: November 17, 2020
Phase: N/A
Study type: Interventional

Some evidence indicates that circadian rhythm may play a role in the pathophysiology of insomnia disorder. This single-blind randomized controlled multicentre prospective study aims to evaluate the possible therapeutic effect of light therapy in modulating the clinical phenotype of patients affected by chronic primary and comorbid insomnia, through the modification of the circadian phase.

NCT ID: NCT05373537 Recruiting - Clinical trials for Autism Spectrum Disorder

Treatment to Improve Sleep in Caregivers With Insomnia and a Child With Autism

Start date: November 5, 2022
Phase: N/A
Study type: Interventional

Autism Spectrum Disorder (ASD) represents one of the most perplexing neurobiological disorders with a prevalence of 1 in 54 children. The lifelong challenging and disruptive behaviors often associated with ASD requires caregivers to change their behavior and modify their environments to provide an ecosystem for optimal outcomes for their child, family and themselves. ASD behaviors can have significant impact on caregivers mental health and family functioning, including the ability to develop and maintain healthy sleep routines. The caregiving population in US has a high prevalence of insomnia; two thirds of caregivers experiencing difficulties falling and/or staying asleep. The prevalence of insomnia in children with ASD is equally high, 60-80% experiencing night waking contributing to poor daytime behavior and disrupted sleep in the caregivers. This pilot RCT will focus on improving caregivers sleep in the context of caring for a child with ASD and insomnia with a multi-disciplinary team. The investigators will compare a home-based tailored CBT for Insomnia (CBT-I) versus a web-based Way to Health CBT-I intervention. This data will support a larger RCT with the Department of Defense funding opportunity through the Congressionally Directed Medical Research Program. This Autism Research Program focuses on improving lives of those living with ASD.

NCT ID: NCT05244889 Recruiting - Migraine Disorders Clinical Trials

Digital CBTI for Comorbid Insomnia in Chronic Migraine

Start date: January 31, 2022
Phase: N/A
Study type: Interventional

The overall aims of the study are: Aim 1: Estimate effect sizes: To estimate the effects of dCBT-I on insomnia symptoms compared to a control group (sleep hygiene education) and estimate the relationship between changes in insomnia symptoms and the reduction in migraines. Aim 2: Explore mechanisms of change: To explore the mechanisms underlining the change in migraine symptoms. Aim 3: Assess barriers to conducting a full-scale RCT: To collect data on recruitment pace and dropouts in both groups, which will help refine the methodology and maximise uptake and retention of a full-scale randomised control trial (RCT). The investigators will conduct qualitative interviews with a select number of participants and practitioners to identify motivators/barriers in uptake of a digitalised version of CBT-I.

NCT ID: NCT05041647 Recruiting - Depression Clinical Trials

Cannabinoids as a Treatment for Insomnia in Major Depression

CANMDD
Start date: August 28, 2023
Phase: Phase 2
Study type: Interventional

This single-site study is a pilot, three-armed, double-blinded, placebo-controlled randomized controlled trial (RCT) that will determine the feasibility of a definitive RCT investigating the use of cannabis oil as a treatment for insomnia in individuals with MDD. The study will also determine whether standard THC with higher CBD vs lower CBD has a differential impact on insomnia. The study will also analyze other important objective parameters of sleep including total sleep time and sleep efficiency from actigraphy data. Polysomnography data will also be analyzed. In addition, standardized, validated instruments will be used to collect data on severity of depressive symptoms, cognitive functioning biological rhythm disruption, daytime sleepiness, health-related quality of life (HRQoL), healthcare resource utilization, work productivity and activity impairment, as well as other side effects, in order to better understand the potential impact of the use of cannabis oil on these important health outcomes.

NCT ID: NCT04632628 Recruiting - Dementia Clinical Trials

Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers

NiteCAPP
Start date: January 2, 2022
Phase: N/A
Study type: Interventional

Over the next 30 years, more than 10 million persons living with dementia in the United States will receive care at home from an unpaid and untrained family caregiver. At home care is preferred by caregivers and persons with dementia alike, but increases the caregiver's risk of insomnia and related negative health outcomes, including depression, anxiety, cognitive disturbances and poor quality of life. Cognitive behavioral therapy for insomnia (CBT-I) is a highly effective and established evidence based treatment for adults of all ages. Although relatively understudied in dementia caregivers, the research by our group and others suggests CBT-I is also efficacious in caregivers. Our team developed a brief (4 session) CBT-I protocol specifically adapted for dementia caregivers (CBT-I) and has shown in person and remote (i.e. telehealth) delivery of this protocol significantly reduces insomnia symptoms and improves mood (moderate to large effects). Given demands on caregivers' time and limited availability of trained CBT-I providers, a web-based version of CBT-I (WebCBT-I; the online treatment will be called NiteCAPP) is needed to increase the accessibility of this efficacious treatment. WebCBT-I will allow for flexible at home scheduling, and the skills needed to monitor caregiver treatment progress can be quickly and efficiently taught to healthcare providers. The overarching goal of this project is to develop and test WebCBT-I in caregivers of persons with dementia. Objectives 1. To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in dementia caregivers with insomnia. 2. To examine changes in the primary clinical outcomes, including complaints of poor sleep, and fatigue. 3. To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health. 4. To examine the mechanistic variables, including arousal (heart rate variability, HRV).