Clinical trial NCT00033865: Yoga as a Treatment for Insomnia
Official title: Yoga as a Treatment for Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insomnia
Keywords: Insomnia
Yoga
Meditation
Behavioral treatment
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2002-04-12
Enrollment: 48
Sex: ALL
Minimum age (years): 25
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Sleep onset latency
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital Division of Sleep Medicine
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Sat Bir Singh Khalsa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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