Trial record 1 of 15 for:    yoga AND insomnia
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Yoga as a Treatment for Insomnia

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00033865
First received: April 11, 2002
Last updated: December 4, 2009
Last verified: December 2009
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Yoga as a Treatment for Insomnia

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Sleep onset latency [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: April 2001
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Yoga treatment for 8 weeks
Behavioral: Yoga, Relaxation Exercises, Sleep Hygiene
Sleep hygiene and relaxation exercises, with additional yoga
No Intervention: 2
Sleep hygiene instructions only
Behavioral: Sleep hygiene and relaxation only
sleep hygiene and relaxation exercises nightly, no yoga

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   25 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • A primary complaint of sleep-onset insomnia for at least 6 months.

    • Reside in the metropolitan Boston area

Exclusion Criteria

  • No current other nonpharmacological treatment for insomnia.
  • Ability or willingness to discontinue use of hypnotic medications.
  • No rotating or night shift work, or transcontinental travel throughout the course of the study protocol.
  • No recent or anticipated major life stressors over the course of the study protocol (e.g. impending divorce or terminal illness of a relative).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00033865

Locations
United States, Massachusetts
Brigham and Women's Hospital Division of Sleep Medicine
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Investigators
Principal Investigator: Sat Bir Singh Khalsa, PhD Brigham and Women's Hospital
  More Information

Publications:
Responsible Party: Sat Bir Singh Khalsa, PhD, Brigham and Women's Hospital, Division of Sleep Medicine
ClinicalTrials.gov Identifier: NCT00033865     History of Changes
Other Study ID Numbers: R21 AT000066-01A1
Study First Received: April 11, 2002
Last Updated: December 4, 2009
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Insomnia
Yoga
Meditation
Behavioral treatment

ClinicalTrials.gov processed this record on September 15, 2014