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Yoga as a Treatment for Insomnia

Primary Purpose

Insomnia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Yoga, Relaxation Exercises, Sleep Hygiene
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Yoga, Meditation, Behavioral treatment

Eligibility Criteria

25 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Brigham and Women's Hospital Division of Sleep Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Yoga treatment for 8 weeks

Sleep hygiene instructions only

Outcomes

Primary Outcome Measures

Sleep onset latency

Secondary Outcome Measures

Full Information

First Posted
April 11, 2002
Last Updated
April 27, 2015
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00033865
Brief Title
Yoga as a Treatment for Insomnia
Official Title
Yoga as a Treatment for Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Yoga, Meditation, Behavioral treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Yoga treatment for 8 weeks
Arm Title
2
Arm Type
No Intervention
Arm Description
Sleep hygiene instructions only
Intervention Type
Behavioral
Intervention Name(s)
Yoga, Relaxation Exercises, Sleep Hygiene
Intervention Description
Sleep hygiene and relaxation exercises, with additional yoga
Primary Outcome Measure Information:
Title
Sleep onset latency
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sat Bir Singh Khalsa, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital Division of Sleep Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7896994
Citation
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.
Results Reference
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PubMed Identifier
8037252
Citation
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.
Results Reference
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PubMed Identifier
7675582
Citation
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.
Results Reference
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PubMed Identifier
8656544
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. doi: 10.1001/jama.1996.03540040057033.
Results Reference
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Citation
Woolfolk RL, Carr-Kaffashan L, McNulty TF. Meditation training as a treatment for insomnia. Behav Ther 1976;7:359-65.
Results Reference
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PubMed Identifier
41856
Citation
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.
Results Reference
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Citation
Schoicket SL, Bertelson AD, Lacks P. Is sleep hygiene a sufficient treatment for sleep-maintenance insomnia? Behav Ther 1988;19:183-90.
Results Reference
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PubMed Identifier
8216184
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. doi: 10.1177/01454455930174005.
Results Reference
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Citation
Koch, U., Volk, S., Heidenreich, T., and Pflug, B. Yoga treatment in psychophysiological insomnia. Journal of Sleep Research 7(Suppl. 2), 137. 1998.
Results Reference
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Citation
Joshi, KS. Yogic treatment of insomnia: An experimental study. Yoga Mimamsa 1992;30:24-26.
Results Reference
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PubMed Identifier
33928908
Citation
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.
Results Reference
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Yoga as a Treatment for Insomnia

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