Trial record 1 of 16 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

April 11, 2002
December 4, 2009
April 2001
December 2008   (final data collection date for primary outcome measure)
Sleep onset latency [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00033865 on ClinicalTrials.gov Archive Site
Not Provided
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Yoga as a Treatment for Insomnia
Yoga as a Treatment for Insomnia

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Insomnia
  • Behavioral: Yoga, Relaxation Exercises, Sleep Hygiene
    Sleep hygiene and relaxation exercises, with additional yoga
  • Behavioral: Sleep hygiene and relaxation only
    sleep hygiene and relaxation exercises nightly, no yoga
  • Experimental: 1
    Yoga treatment for 8 weeks
    Intervention: Behavioral: Yoga, Relaxation Exercises, Sleep Hygiene
  • No Intervention: 2
    Sleep hygiene instructions only
    Intervention: Behavioral: Sleep hygiene and relaxation only

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
December 2008
December 2008   (final data collection date for primary outcome measure)

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).
Both
25 Years to 59 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00033865
R21 AT000066-01A1
Not Provided
Sat Bir Singh Khalsa, PhD, Brigham and Women's Hospital, Division of Sleep Medicine
National Center for Complementary and Alternative Medicine (NCCAM)
Not Provided
Principal Investigator: Sat Bir Singh Khalsa, PhD Brigham and Women's Hospital
National Center for Complementary and Alternative Medicine (NCCAM)
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP