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Primary Insomnia clinical trials

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NCT ID: NCT00555750 Completed - Primary Insomnia Clinical Trials

Sleep Loss and Mechanisms of Impaired Glucose Metabolism

Start date: March 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to test the effects of sleep and eszopiclone, a drug that helps people sleep, on how the body processes glucose (sugar). Eszopiclone is approved by the U.S. Food and Drug Administration (FDA) for sale for the treatment of insomnia. It is marketed in the United States as LUNESTA. Main Hypothesis: Primary insomnia is associated with impairments of glucose metabolism that can be reversed by two months of eszopiclone for the primary insomnia

NCT ID: NCT00551148 Completed - Primary Insomnia Clinical Trials

A Dose-ranging, Multicenter Polysomnography Trial of PD 0200390 in Adults With Primary Insomnia

Start date: October 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to further explore an effective dose range of PD0200390 for the treatment of patients with insomnia.

NCT ID: NCT00548340 Completed - Primary Insomnia Clinical Trials

VEC-162 Study in Adult Patients With Primary Insomnia

Start date: November 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of a 5 week double-blind treatment period of VEC-162 as compared to placebo in male and female patients with primary insomnia.

NCT ID: NCT00520832 Completed - Primary Insomnia Clinical Trials

A Pilot Study Of The Effects Of Microcurrent On Three Sleep Surveys

Start date: September 2007
Phase: Phase 2
Study type: Interventional

Participants identified as having primary insomnia will be randomly assigned to groups receiving microcurrent stimulation or sham in a double-blind randomized controlled trial. The microcurrent device used is FDA approved for the treatment of insomnia. The hypothesis is that the experimental group will have significantly improved scores on three sleep surveys after treatment while the sham group will not.

NCT ID: NCT00515177 Completed - Chronic Insomnia Clinical Trials

Mindfulness Versus Pharmacotherapy for Chronic Insomnia: A Pilot Study

MVP#1
Start date: August 2007
Phase: Phase 2/Phase 3
Study type: Interventional

Chronic insomnia is a major public health problem that affects about 10% of adults and is associated with serious and distressful health consequences such as depression, anxiety and reduced quality of life. Sleep medications are effective, but side effects, costs and uncertain long term efficacy call for non-pharmacologic alternatives. Mindfulness-Based Stress Reduction (MBSR), a standardized program of training in mindfulness meditation and yoga, is a promising new approach for treating chronic insomnia. MBSR was developed to facilitate adaptation to the stressors of medical illness. It is hypothesized that mindfulness training reduces arousal and unhelpful cognitions that promote and sustain chronic insomnia. The Mindfulness Versus Pharmacotherapy trial (MVP#1) is a pilot study designed to establish the feasibility and determine the optimal design for a full-scale trial comparing MBSR to prescribed sleep medication for treatment of chronic insomnia. For this pilot, we will randomize persons with primary chronic insomnia (actual sample of 30 persons) to 2 groups : 1) MBSR (8-weeks of group instruction followed by 3-months of home practice); and 2) PCT (3 mg of LUNESTA(eszopiclone) nightly for 8-weeks followed by 3-months of "as needed" use). Both groups will have telephone monitoring for side effects, adherence tracking, and objective sleep assessment by actigraphy. The primary outcomes are sleep quality, sleep quantity and insomnia severity assessed by well-validated self-report scales, objective sleep parameters measured by wrist actigraphy, depression and anxiety symptoms, health-related quality of life and workplace productivity. We hypothesize that those in the MBSR group will have improved sleep outcomes. Outcomes will be assessed at 8-weeks (the end of the active intervention phase) and 5 months follow-up. Outcomes will be compared to baseline values and measures reflecting proposed mechanisms of action to determine if clinically important impacts are likely to be obtainable in a full-scale trial. After follow-up data have been collected, participants will be invited to participate in focus groups to share their impressions of the study interventions to identify issues that could be addressed in a full-scale trial. Our long-range goal is to provide evidence-based recommendations for safe, practical and cost-effective non-pharmacologic treatment options for chronic insomnia.

NCT ID: NCT00420810 Terminated - Primary Insomnia Clinical Trials

Adult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED)

Start date: September 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is determine whether this drug will improve your insomnia in terms of decreasing your time to fall asleep and allowing you to stay asleep longer. The drug will be compared against placebo in order to determine if there's a difference.

NCT ID: NCT00415714 Recruiting - Primary Insomnia Clinical Trials

Safety and Efficacy of an Ambulatory Biofeedback Device for Primary Insomnia

Start date: September 2006
Phase: N/A
Study type: Interventional

The objective of this study is to determine the efficacy of a portable biofeedback device on improving sleep latency and other sleep variables such as nocturnal awake time and daytime functioning in persons with primary insomnia.

NCT ID: NCT00414037 Terminated - Primary Insomnia Clinical Trials

How do Sleeping Pills Affect Pain in the Brain?

Start date: December 2006
Phase: Phase 4
Study type: Interventional

If you are age 20-55 years old and have trouble falling or staying asleep, then please contact a UCSD research team to find out how a study drug affects these symptoms and how your brain works. This is a one-week experimental pain research study using a study drug compared to placebo. Your participation will include questionnaires, a physical exam and functional Magnetic Resonance Imaging (fMRI) brain imaging techniques. We will test pain perception by applying brief mild to moderate heat pain to the forearm, and also have you perform simple computer tasks while we image and record brain activity using fMRI.

NCT ID: NCT00397189 Completed - Primary Insomnia Clinical Trials

Efficacy and Safety of Circadin® 2 mg in the Treatment of Primary Insomnia Patients

Start date: October 2006
Phase: Phase 3
Study type: Interventional

This is a randomised, placebo controlled study to evaluate the efficacy of a 3 week treatment period with Circadin® 2 mg in shortening sleep latency in patients with primary insomnia aged 18-80 with melatonin deficiency.

NCT ID: NCT00368056 Completed - Primary Insomnia Clinical Trials

Effects of One Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability

Start date: April 2005
Phase: Phase 3
Study type: Interventional

To assess next day driving ability and psychomotor/memory function following a single night time dose of eszopiclone in insomnia patients.