Official Title: “Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia”

The purpose of this study is to evaluate the change in measures of physiological arousal before and after behavioral treatment of insomnia.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2008

There is good evidence that physiological arousal, associated with sustained activation of the hypothalamic-pituitary axis and the sympathetic nervous system, is an underlying cause of chronic insomnia. Accordingly, relaxation-related treatments that address elevated cognitive and somatic arousal have been effective for insomnia. Previous studies have documented the effectiveness of behavioral treatments in reducing activation of the hypothalamic-pituitary axis and the sympathetic nervous system and in the treatment of specific medical disorders including insomnia. The aim of this proposal is to evaluate the hypothesis that improvements in chronic psychophysiological insomnia following a behavioral treatment are tightly associated with reduction of arousal in the hypothalamic-pituitary axis, as measured by plasma cortisol, and in the sympathetic nervous system, as measured by urinary catecholamines. Objective measures of sleep will be derived from polysomnographic recordings from subjects randomized into a 10-week active behavioral treatment or placebo behavioral control treatment group. Continuous 24-hour evaluation of cortisol and catecholamines will be performed under controlled laboratory conditions before and after treatment. We anticipate significant reductions in cortisol and catecholamines in the active treatment group as compared with the control group. We also anticipate that the active treatment will yield reductions in related measures of arousal including heart rate, autonomic arousal (as determined from heart rate variability), and body temperature. Given reported evidence that melatonin levels are chronically low in insomnia we anticipate an increase in the sleep-related hormone melatonin in the yoga treatment group. If achieved, these results will provide a novel demonstration of a reduction of arousal in a behavioral insomnia treatment and a behaviorally enhanced melatonin secretion under controlled laboratory conditions.

Intervention(s) in this Clinical Trial

• Behavioral: mental control of attention
• Behavioral: breath regulation
• Behavioral: physical exercise

Primary Measures

• plasma cortisol
• plasma melatonin
• urinary catecholamines
• heart rate variability
• subjective sleep efficiency
• objective sleep efficiency

Secondary Measures

• actigraphy
• EEG
• subjective mood
• depression
• anxiety

Inclusion Criteria:

• primary insomnia for 6 months
• average total wake time >60 minutes and sleep efficiency <80%
• at least 1 daytime complaint due to insomnia
• adequate opportunity and circumstance for sleep

Exclusion Criteria:

• current psychiatric condition
• medical condition that interferes with sleep
• pregnancy
• rotating shift work, night work or transcontinental travel during study
• anticipated major life stressor over the course of the study
• use of hypnotic or psychoactive medications
• no idiopathic or sleep state misperception insomnia

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 59 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Center for Complementary and Alternative Medicine (NCCAM)

Overall Clinical Trial Officials and Contacts

Sat Bir S Khalsa, Ph.D. Principal Investigator Brigham and Women's Hospital, Harvard Medical School  

Overall Contact: Sat Bir S Khalsa, Ph.D. (617) 732-7994 khalsa@hms.harvard.edu

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00303342

Study ID Number: R01 AT002490

ClinicalTrials.gov Identifier: NCT00303342

Health Authority: United States: Federal Government