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Chronic Insomnia clinical trials

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NCT ID: NCT03305354 Completed - Chronic Insomnia Clinical Trials

Mobile Intervention to Improve Functional Health and Community Engagement of Post-9/11 Veterans With Chronic Insomnia

Start date: January 31, 2018
Phase: N/A
Study type: Interventional

Veterans of the most recent wars in Afghanistan and Iraq (collectively, post 9/11 Veterans) have notable sleep problems including chronic insomnia. Here, the investigators plan to compare two groups of veterans with insomnia: (1) one group that completes a 6 week self-management-guided use of a mobile app based on cognitive behavioral therapy for insomnia (CBTI alone) and (2) one group that completes a 6 week combined self-management-guided use of the mobile CBTI app in addition to a physical activity (PA) intervention (CBTI + PA). The investigators hypothesize that the group receiving the adjunctive 6-week PA intervention will have better subjective and objective sleep, higher step counts, and better functional health and social and community integration than those receiving CBTI alone. This pilot work will provide evidence to guide the design of a future randomized controlled trial.

NCT ID: NCT03171519 Completed - Chronic Insomnia Clinical Trials

Effects of Exercise and Acupuncture on Chronic Insomnia

Start date: September 25, 2017
Phase: N/A
Study type: Interventional

Introduction: Chronic insomnia is a sleep disorder, characterized by difficulty in initiating and/or maintaining sleep, presence of non-restorative sleep, frequent awakenings or difficulty returning to sleep after each awakening, with a frequency of 3 nights/week, for at least 3 months. Pharmacologic therapy is the most commonly method used for its treatment, however, pharmacotherapy is associated with side effects. Thus, non-pharmacological therapies have been suggested as an alternative. Objective: To verify the effects of exercise associated with acupuncture on chronic insomnia. METHODS: 40 patients with chronic insomnia will be randomly assigned into two groups: CONTROL (n = 20) and ACUPUNCTURE (n = 20). The volunteers of the CONTROL group will be submitted to 12 weeks of aerobic exercise, performed on a treadmill, with frequency of 3 times / week and duration of 50 minutes / day. ACUPUNCTURE volunteers will perform aerobic exercise, following the protocol of the CONTROL group, plus acupuncture therapy once a week. The sleep evaluation will be evaluated by polysomnography and questionnaires. Expected Results: A 12-week combined therapy could potentiate the previously described positive effects of exercise in the treatment of chronic insomnia.

NCT ID: NCT03160404 Completed - Chronic Insomnia Clinical Trials

Zolpidem or Exercise for Insomnia?

Start date: April 16, 2018
Phase: Early Phase 1
Study type: Interventional

Introduction: The prevalence of chronic insomnia in the general population is between 10 and 15%. The therapy commonly prescribed for its treatment is pharmacological, however, there are several non-pharmacological alternatives being studied, among them physical exercise. Although some studies have described the effect of exercise on sleep in insomnia, there are no studies comparing exercise and drugs in the treatment of chronic insomnia, or its effect as coadjuvant therapy. Objective: To compare the acute and chronic effects of aerobic exercise and zolpidem on sleep quality, mood and quality of life in patients with chronic insomnia. Material and Methods: 30 patients with chronic insomnia will be randomly assigned into two groups: EXERCISE (n=15) or ZOLPIDEM (n=15). The patients of EXERCISE group will be included in an aerobic exercise program, performed in 50% of reserve heart rate, on a treadmill (50 minutes, 3 times/week), during 6 weeks. The ZOLPIDEM group will be treated with zolpidem (10mg/night) during 6 weeks. Polysomnography, actigraphy, sleep diary and questionnaires will be used the evaluate sleep pattern. Mood and quality of life will be investigated by POMS and SF-36 questionnaires. Hypothesis: Considering previous studies have demonstrated positive effects of aerobic exercise in the insomnia symptoms, the hypothesis of this study is that aerobic exercise, performed at moderate intensity, can control the symptoms of chronic insomnia similarly to pharmacological therapy.

NCT ID: NCT03075683 Completed - Chronic Pain Clinical Trials

Internet-based CBT for Insomnia in Chronic Pain

IBIS
Start date: February 1, 2017
Phase: N/A
Study type: Interventional

The main goal is to study the effect of therapist-guided internet-delivered cognitive behavioural therapy for insomni comorbid with chronic pain in a clinical sample.

NCT ID: NCT02871414 Completed - Chronic Insomnia Clinical Trials

REST: Restoring Effective Sleep Tranquility in College Veterans With Service-Related Injuries

Start date: July 2015
Phase: N/A
Study type: Interventional

The purpose of the project is to improve the sleep quality and sleep duration of post 9/11 veterans seeking college degrees. Preliminary research findings within CSU's New Start for Student Veterans program indicate veterans with service-related injuries report difficulties with sleep quality and duration. The REST program will recruit 24 college veterans and engage them in a seven-week multi component sleep improvement program using evidence-based educational and behavioral change supports that are considered best practice for improving sleep quality. The investigators' scientific objectives in this application are to establish the efficacy of a group-based sleep education and sleep-skills intervention to improve sleep quality and duration, and to advance understanding of relationships between participants' sleep-related knowledge and behaviors associated with improved sleep quality and duration in veterans with service-related injuries in college. The investigators will initially engage 8 participants to establish treatment fidelity and participant satisfaction of the 7-week group intervention. This will be followed by engaging 16 additional participants in the 7-week group intervention, 8 will be randomly placed as wait-list controls and then receive the intervention. The 7-week group intervention will take place within the CSU Occupational Therapy Department, and all assessments will be completed using a web-based survey.

NCT ID: NCT02774642 Completed - Chronic Insomnia Clinical Trials

Integrated CBT-I and PE on Sleep and PTSD Outcomes (Impact Study)

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

This study aims to examine whether integrating insomnia and PTSD treatment will enhance sleep, PTSD, and quality of life outcomes. This is a randomized control trial comparing integrated evidence based CBT-I into PE (CBTI-PE) versus to a non-active sleep component plus PE (hygiene-PE) to optimize PTSD, sleep, and quality of life outcomes in 90 Veterans. Such benefits would further the VA's commitment to improving the mental health, recovery, and community reintegration of Veterans detailed in the 2014-2020 VHA Strategic Plan. Findings from the proposed study offer a unique opportunity to determine the malleability of mechanisms (e.g., Total sleep time, Sleep efficiency) that can improve recovery outcomes among this vulnerable population and to inform future treatment development and research. Improved PTSD, insomnia, and quality of life outcomes can decrease risk of chronic impairment and ultimately help affected Veterans live richer, more productive lives.

NCT ID: NCT02755051 Completed - Clinical trials for Autism Spectrum Disorder

Targeting Sleep in Kids With Autism Spectrum Disorder

Start date: July 2016
Phase: N/A
Study type: Interventional

Children with Autism Spectrum Disorder (ASD) and insomnia, and their parent(s) will undergo 8 sessions of Cognitive Behavioral Therapy designed for Children with Chronic Insomnia and ASD (CBT-CI-A). Treatment delivery will be assessed for each session. Treatment receipt will be assessed at the end of session 3. Treatment enactment will be assessed throughout treatment, post-treatment, and follow-up. Sleep and secondary outcomes (child daytime behavior, parent sleep) will be collected at baseline, post-treatment, and 1-month follow-up. Study Flow: Baseline (wk1-2) ---> CBT-CI-A (wk3-10) ---> Post-Treatment (wk11-12) --->Wks 13-16 --->Follow-up (wk 17-18) Session: 1. Sleep education 2. Sleep scheduling, limit setting, and stimulus control 3. Teaching relaxation strategies and other adaptive coping skills 4. Parenting strategies (differential attention, rewards, consequences) 5. Identification of maladaptive & adaptive cognitions 6. Problem solving & communication skills 7. Sleep restriction; bright light to change circadian rhythms 8. Review gains and plan for long-term maintenance

NCT ID: NCT02724800 Completed - Chronic Insomnia Clinical Trials

Implementation of Brief Insomnia Treatments - Clinical Trial

iBIT
Start date: April 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to directly compare the effectiveness of two interventions for insomnia: Brief Behavioral Treatment for Insomnia (BBTI) vs. Cognitive Behavioral Therapy for Insomnia (CBTI).

NCT ID: NCT02688569 Completed - Chronic Insomnia Clinical Trials

Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study

SPIN-CWP
Start date: October 2016
Phase: N/A
Study type: Interventional

This randomized controlled clinical trial will examine the effects of Cognitive Behavioral Therapy (CBT-) in patients with comorbid chronic widespread pain (CWP) and insomnia. Specific Aims: 1. To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in patients with comorbid CWP and insomnia. 2. To examine changes in the primary clinical outcomes, including chronic pain, complaints of poor sleep, and fatigue compared to the waitlist control (WLC). 3. To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health compared WLC. 4. To examine the mechanistic variables, including arousal (heart rate variability, HRV), CS (thermal response) and neural plasticity (brain function and structure) - compared to WLC.

NCT ID: NCT02660385 Completed - Pain Clinical Trials

Insomnia Self-Management in Heart Failure

HSS
Start date: March 7, 2016
Phase: N/A
Study type: Interventional

Chronic insomnia may contribute to the development and exacerbation of heart failure (HF), incident mortality and contributes to common and disabling symptoms (fatigue, dyspnea, anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and subjective functional performance. The purposes of the study are to evaluate the sustained effects of CBT-I on insomnia severity, sleep characteristics, daytime symptoms, and functional performance over twelve months among patients who have stable chronic HF and chronic insomnia. The effects of the treatment on outcomes of HF (hospitalization, death) and costs of the treatment will also be examined. A total of 200 participants will be randomized to 4 bi-weekly group sessions of cognitive behavioral therapy for CBT-I (behavioral was to improve insomnia and sleep) or HF self-management education. Participants will complete wrist actigraph (wrist-watch like accelerometer) measures of sleep, diaries, reaction time, and 6 minute walk test distance. They will also complete self-report measures of insomnia, sleep, symptoms, and functional performance. In addition the effects on symptoms and function over a period of one year.