Yoga as a Treatment for Insomnia

NCT ID: NCT00033865

Last Updated: 2015-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Yoga treatment for 8 weeks

Group Type EXPERIMENTAL

Yoga, Relaxation Exercises, Sleep Hygiene

Intervention Type BEHAVIORAL

Sleep hygiene and relaxation exercises, with additional yoga

2

Sleep hygiene instructions only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Yoga, Relaxation Exercises, Sleep Hygiene

Sleep hygiene and relaxation exercises, with additional yoga

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

25 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Responsible Party

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Brigham and Women's Hospital, Division of Sleep Medicine

Principal Investigators

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Sat Bir Singh Khalsa, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital Division of Sleep Medicine

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Murtagh DR, Greenwood KM. Identifying effective psychological treatments for insomnia: a meta-analysis. J Consult Clin Psychol. 1995 Feb;63(1):79-89. doi: 10.1037//0022-006x.63.1.79.

Reference Type BACKGROUND
PMID: 7896994 (View on PubMed)

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. doi: 10.1176/ajp.151.8.1172.

Reference Type BACKGROUND
PMID: 8037252 (View on PubMed)

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. doi: 10.2466/pms.1995.80.2.507.

Reference Type BACKGROUND
PMID: 7675582 (View on PubMed)

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. doi: 10.1001/jama.1996.03540040057033.

Reference Type BACKGROUND
PMID: 8656544 (View on PubMed)

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

Reference Type BACKGROUND

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. doi: 10.1037//0022-006x.47.6.1072. No abstract available.

Reference Type BACKGROUND
PMID: 41856 (View on PubMed)

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

Reference Type BACKGROUND

Khalsa SBS, Goldstein MR. Treatment of chronic primary sleep onset insomnia with Kundalini yoga: a randomized controlled trial with active sleep hygiene comparison. J Clin Sleep Med. 2021 Sep 1;17(9):1841-1852. doi: 10.5664/jcsm.9320.

Reference Type DERIVED
PMID: 33928908 (View on PubMed)

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. doi: 10.1177/01454455930174005.

Reference Type BACKGROUND
PMID: 8216184 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

Other Identifiers

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R21 AT000066-01A1

Identifier Type: -

Identifier Source: org_study_id

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