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Yoga as a Treatment for Insomnia

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ClinicalTrials.gov Identifier: NCT00033865
Recruitment Status : Completed
First Posted : April 12, 2002
Last Update Posted : April 28, 2015
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Insomnia Behavioral: Yoga, Relaxation Exercises, Sleep Hygiene Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Yoga as a Treatment for Insomnia
Study Start Date : April 2001
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Sleep

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Yoga treatment for 8 weeks
 Behavioral: Yoga, Relaxation Exercises, Sleep Hygiene
Sleep hygiene and relaxation exercises, with additional yoga
No Intervention: 2
Sleep hygiene instructions only


Outcome Measures
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Primary Outcome Measures :
  1. Sleep onset latency [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00033865


Locations
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United States, Massachusetts
Brigham and Women's Hospital Division of Sleep Medicine
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Sat Bir Singh Khalsa, PhD Brigham and Women's Hospital
More Information
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Publications:
Integration of behavioral and relaxation approaches into the treatment of chronic pain and insomnia. NIH Technology Assessment Statement 1995;1-34.
Woolfolk RL, Carr-Kaffashan L, McNulty TF. Meditation training as a treatment for insomnia. Behav Ther 1976;7:359-65.
Schoicket SL, Bertelson AD, Lacks P. Is sleep hygiene a sufficient treatment for sleep-maintenance insomnia? Behav Ther 1988;19:183-90.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sat Bir Singh Khalsa, PhD, Brigham and Women's Hospital, Division of Sleep Medicine
ClinicalTrials.gov Identifier: NCT00033865    
Other Study ID Numbers: R21 AT000066-01A1
First Posted: April 12, 2002    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 2015
Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Insomnia
Yoga
Meditation
Behavioral treatment
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Mental Disorders