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Clinical Trial for Insomnia-11/02

Yoga as a Treatment for Insomnia

This study is currently recruiting patients.

Sponsored by National Center for Complementary and Alternative Medicine (NCCAM)

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.

***PARTICIPANTS MUST LIVE IN THE METROPOLITAN BOSTON AREA IN ORDER TO ENROLL IN THIS STUDY***

Condition Treatment or Intervention Phase Insomnia Behavior: Yoga, Relaxation Exercises, Sleep Hygiene Phase II

MEDLINEplus related topics: Sleep Disorders

Study Type: Interventional Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further Study Details:

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 - 59 Years

Genders Eligible for Study: Both

Criteria Inclusion criteria

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

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).

Location and Contact Information

Sat Bir Singh Khalsa, PhD (617) 732-7994 khalsa@hms.harvard.edu

Massachusetts Brigham and Women's Hospital Division of Sleep Medicine, Boston, Massachusetts, 02115, United States;

Recruiting Study chairs or principal investigators

Sat Bir Singh Khalsa, PhD, Principal Investigator Brigham and Women’s Hospital

More Information

Publications

Murtagh DR, Greenwood KM. Identifying effective psychological treatments for insomnia: a meta-analysis. J Consult Clin Psychol. 1995 Feb;63(1):79-89.

Morin CM, Culbert JP, Schwartz SM. Nonpharmacological interventions for insomnia: a meta-analysis of treatment efficacy. Am J Psychiatry. 1994 Aug;151(8):1172-80.

Choliz M. A breathing-retraining procedure in treatment of sleep-onset insomnia: theoretical basis and experimental findings. Percept Mot Skills. 1995 Apr;80(2):507-13.

Woolfolk RL, Carr-Kaffashan L, McNulty TF. Meditation training as a treatment for insomnia. Behav Ther 1976;7:359-65.

Carr-Kaffashan L, Woolfolk RL. Active and placebo effects in treatment of moderate and severe insomnia. J Consult Clin Psychol. 1979 Dec;47(6):1072-80. No abstract available.

Schoicket SL, Bertelson AD, Lacks P. Is sleep hygiene a sufficient treatment for sleep-maintenance insomnia? Behav Ther 1988;19:183-90.

Jacobs GD, Rosenberg PA, Friedman R, Matheson J, Peavy GM, Domar AD, Benson H. Multifactor behavioral treatment of chronic sleep-onset insomnia using stimulus control and the relaxation response. A preliminary study. Behav Modif. 1993 Oct;17(4):498-509.

Koch, U., Volk, S., Heidenreich, T., and Pflug, B. Yoga treatment in psychophysiological insomnia. Journal of Sleep Research 7(Suppl. 2), 137. 1998.

Joshi, KS. Yogic treatment of insomnia: An experimental study. Yoga Mimamsa 1992;30:24-26.

Study ID Numbers 1 R21 AT00266-01A1 Date study started April 2001; Study Completion Date September 2005 Record last reviewed October 2002 NLM Identifier NCT00033865

ClinicalTrials.gov processed this record on 2002-11-


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