Yoga as a Treatment for Insomnia

Insomnia Clinical Trial

Official title:

Yoga as a Treatment for Insomnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00033865
• Other study ID #: R21 AT000066-01A1
• Status: Completed
• Phase: Phase 2
• First received: April 11, 2002
• Last updated: April 27, 2015
• Start date: April 2001
• Est. completion date: December 2008

Study information

• Verified date: April 2015
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 59 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Behavioral:
• Yoga, Relaxation Exercises, Sleep Hygiene
Sleep hygiene and relaxation exercises, with additional yoga

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital Division of Sleep Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

Chóliz 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. — View Citation

Integration of behavioral and relaxation approaches into the treatment of chronic pain and insomnia. NIH Technology Assessment Panel on Integration of Behavioral and Relaxation Approaches into the Treatment of Chronic Pain and Insomnia. JAMA. 1996 Jul 24-31;276(4):313-8. Review. — View Citation

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. — View Citation

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

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

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. — View Citation

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

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep onset latency		8 weeks	No