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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00033865 |
The purpose of this study is to evaluate the effectiveness of a daily, 8-week treatment for insomnia using yoga, relaxation exercises or sleep hygiene.
Condition | Intervention | Phase |
---|---|---|
Insomnia |
Behavioral: Yoga, Relaxation Exercises, Sleep Hygiene Behavioral: Sleep hygiene and relaxation only |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Yoga as a Treatment for Insomnia |
Estimated Enrollment: | 48 |
Study Start Date: | April 2001 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Yoga treatment for 8 weeks
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Behavioral: Yoga, Relaxation Exercises, Sleep Hygiene
Sleep hygiene and relaxation exercises, with additional yoga
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2: No Intervention
Sleep hygiene instructions only
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Behavioral: Sleep hygiene and relaxation only
sleep hygiene and relaxation exercises nightly, no yoga
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Insomnia is a sleep disorder characterized by a chronic difficulty in initiating and maintaining sleep which has a relatively high prevalence and a significant socioeconomic cost. There is good evidence that cognitive and/or physiological arousal, associated with sustained sympathetic activation, is one of the underlying causes of insomnia. Relaxation treatments such as progressive relaxation and meditation which address the cognitive and somatic arousal associated with insomnia have been found to be effective. Yoga is a comprehensive discipline which includes physical exercises, postures, breathing techniques, and meditation, for the purpose of improving health and well being. Research studies have documented the effectiveness of yoga in reducing sympathetic activation and cognitive and somatic arousal and in the treatment of specific medical disorders. Although it has been used and recommended for the treatment of insomnia, its effectiveness has not been evaluated in a randomized, controlled study. The aim of this proposal is to evaluate the effectiveness of yoga, relaxation exercises or sleep hygiene in the treatment of chronic psychophysiological insomnia. A subjective measure of sleep onset latency will be derived from daily sleep diaries, and an objective measure will be drawn from polysomnographic recordings. Sleep onset latency will be evaluated before and after a two month treatment period in a total of 48 young men and women who have been carefully screened for psychiatric and medical disorders. Subjects will be assigned to a yoga, relaxation exercise, or sleep hygiene treatment group. We anticipate that yoga practice will prove to be an effective treatment for insomnia which will yield significant improvements in sleep onset latency. We also anticipate that these improvements will be maintained at long-term follow up evaluation.
Ages Eligible for Study: | 25 Years to 59 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
A primary complaint of sleep-onset insomnia for at least 6 months.
Exclusion Criteria
Contact: Sat Bir Singh Khalsa, PhD | (617) 732-7994 | khalsa@hms.harvard.edu |
United States, Massachusetts | |
Brigham and Women's Hospital Division of Sleep Medicine | Recruiting |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Sat Bir Singh Khalsa, PhD | Brigham and Women's Hospital |
Responsible Party: | Brigham and Women's Hospital, Division of Sleep Medicine ( Sat Bir Singh Khalsa, PhD ) |
Study ID Numbers: | R21 AT000266-01A1 |
Study First Received: | April 11, 2002 |
Last Updated: | August 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00033865 |
Health Authority: | United States: Federal Government |
Insomnia Yoga Meditation Behavioral treatment |
Sleep Initiation and Maintenance Disorders Mental Disorders Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic |
Nervous System Diseases |