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Insomnia clinical trials

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NCT ID: NCT02248675 Completed - Depression Clinical Trials

Adjunctive Brief Behavioral Treatment of Insomnia (BBTI) for Sleep Intervention (SI)

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

There is a strong association between sleep disturbance and suicidal thoughts and behaviors. Sleep disturbance is also highly comorbid with other common conditions associated with suicide such as depression and posttraumatic stress disorder. Accordingly, this application focuses on improving sleep as a novel suicide prevention strategy that can be delivered to a broad range of Veterans. This pilot proposal specifically examines how Cognitive Behavioral Therapy for Insomnia, an efficacious treatment for insomnia, may reduce suicidal ideation in Veterans who also suffer from additional conditions. The proposal further suggests that adding this sleep intervention to usual care may further enhance overall care by increasing the utilization of recommended treatments for depression and posttraumatic stress disorder.

NCT ID: NCT02232204 Completed - Insomnia Clinical Trials

Sleep and Ventricular Arrhythmias Study

SAVE
Start date: October 2009
Phase: Phase 2
Study type: Interventional

This is a single-center, randomized controlled trial study design. Enrolled participants have a cardiovascular condition for which they are undergoing implantable cardioverter defibrillator (ICD) therapy and comorbid insomnia. Participants were randomized to a behavioral intervention for insomnia in ICD patients or a waitlist control. The treatment intervention period lasted 4 weeks with a telephone booster session administered at 3 month follow-up. The objective of the study is to examine the impact of a brief therapy combining established behavioral approaches to treating insomnia with novel components to target negative cognitions and anxieties associated with cardiac disease and ICD implantation. Primary patient outcomes include sleep, psychological functioning, daytime functioning, cardiac functioning, cognitive performance, and ICD adjustment.

NCT ID: NCT02165839 Completed - Breast Cancer Clinical Trials

Brief Behavioral Intervention for Insomnia During Chemotherapy

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

PRIMARY OBJECTIVE(S): To evaluate the efficacy of the Brief Behavioral Therapy for Insomnia (BBT-I) in treating insomnia among breast cancer patients receiving chemotherapy. SECONDARY OBJECTIVE(S): - To evaluate the efficacy of the BBT-I in treating cancer-related symptoms such as cancer-related fatigue and cognitive difficulties in breast cancer patients receiving chemotherapy. - To examine potential moderators and mediators of BBT-I intervention effects on insomnia, cognitive difficulties, and fatigue. In particular, we are interested in age, depression and anxiety and side effects (hot flashes) as potential moderators of the intervention effects as well as evaluating modifiable behavioral and physiological mechanisms as hypothesized mediators

NCT ID: NCT02163564 Completed - Depression Clinical Trials

Development of an Insomnia Treatment for Depressed Adolescents

Start date: April 2012
Phase: N/A
Study type: Interventional

Major depressive disorder (MDD) occurs at least 11% of adolescents and approximately 53-90% of those adolescents have insomnia. If left untreated, insomnia increases the risk of relapse and recurrence of depressive episodes, unintentional injuries, poor school performance, substance use, obesity, and the risk for suicide. This project seeks to develop a nonpharmacological treatment for insomnia in adolescents with depression that is feasible and effective. The specific methodologies that will help accomplish these results are: 1) use of focus groups of adolescents with depression and insomnia to determine how the current standard, nonpharmacological treatment for insomnia (cognitive-behavioral therapy for insomnia; CBTI) among adults can be modified for use by adolescents with depression and 2) determine the preliminary effectiveness, feasibility, and tolerability of group CBTI in adolescents with depression (CBTI-AD) developed using feedback from the focus groups. This project will help to improve the quality and scope of delivery of mental health services in Michigan by a) gaining a greater understanding of how sleep disturbance may perpetuate depression in adolescents and b) to provide mental health professionals with a nonpharmacological treatment option for insomnia in adolescents with depression.

NCT ID: NCT02156271 Completed - Insomnia Clinical Trials

Mechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation and Insulin Resistance

Start date: July 2007
Phase: Phase 4
Study type: Interventional

The purpose of this study is to help scientist better understand the effect of a 12-week single daily evening dose of ramelteon (Rozerem ©), a drug that has been approved by the U. S. Food and Drug Administration (FDA) for the treatment of insomnia (trouble falling asleep or staying asleep). The study will measure levels of inflammation, fasting insulin and fasting glucose (sugar) in subjects who are taking either ramelteon (8 mg) or placebo.

NCT ID: NCT02153788 Completed - Insomnia Clinical Trials

Efficacy and Safety of Temazepam in HIV Seropositive Patients With Insomnia

Start date: September 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to test two study drugs, one of which is temazepam (15mg) and one of which is a placebo (an inactive substance that looks just like the temazepam), to see if insomnia (trouble sleeping) can be reduced in patients with HIV infection. Placebos are given in research studies to try and make sure that subjects are responding to the effects of the study drug and not to other factors, like the attention they are receiving. If you decide to take part in this study, you will take 1 capsule of study drug every night approximately 30 minutes before bedtime for approximately 12 weeks. This study is to test the study drug called temazepam for the treatment of insomnia (trouble sleeping) in patients with HIV infection. Temazepam has been approved by the FDA for the treatment of insomnia. However, because this study requires treatment for 12 weeks instead of the 7 to 10 days approved by the FDA, the use of temazepam is considered to be investigational in this study.

NCT ID: NCT02153086 Completed - Insomnia Clinical Trials

Ramelteon 8 mg Tablets Specified Drug-use Survey: <Long-term Survey on Insomnia Accompanied by Difficulty Falling Asleep> − Transitional Survey From the Preceding Drug-use Survey −

Start date: March 2011
Phase: N/A
Study type: Observational

The purpose of this survey is to examine the safety and efficacy of long-term use of ramelteon tablets (Rozerem 8 mg Tablets) in patients with difficulty falling asleep associated with insomnia in daily medical practice.

NCT ID: NCT02120989 Completed - Insomnia Clinical Trials

Researching Effective Sleep Treatments (Project REST)

REST
Start date: May 2014
Phase: N/A
Study type: Interventional

We will undertake initial development of a new behavioral sleep intervention (i.e., partner-assisted Cognitive Behavioral Therapy for Insomnia; CBT-I), based closely on the gold standard treatment, CBT-I. We will examine if the new treatment has a positive impact on subjective and objective sleep and quality of life in a clinic-based sample. Secondary aims will examine treatment adherence and maintenance of therapeutic gains as well as relationship satisfaction and broader psychiatric functioning.

NCT ID: NCT02117388 Completed - Insomnia Clinical Trials

Treatments for Insomnia: Mediators, Moderators and Quality of Life

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

The purpose of this study is to evaluate the relative efficacy and effectiveness of specific components of cognitive behavioral therapies for insomnia: sleep restriction (SR) and cognitive therapy (CT) in comparison to combined SR and CT (SR+CT).

NCT ID: NCT02092844 Completed - Insomnia Clinical Trials

Cognitive Behavioral Therapy for Insomnia and Nocturnal Hot Flashes in Menopause

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

The primary aim of the current study is to evaluate the effectiveness of a Cognitive Behavioral Therapy intervention in the treatment of menopause-associated insomnia and nocturnal hot flashes.