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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00303342 |
The purpose of this study is to evaluate the change in measures of physiological arousal before and after behavioral treatment of insomnia.
Condition | Intervention | Phase |
---|---|---|
Insomnia |
Behavioral: mind body treatment Behavioral: desensitization |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia |
Estimated Enrollment: | 60 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
mind body treatment: Experimental
regulation of attention, respiration and posture
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Behavioral: mind body treatment
regulation of attention, respiration and posture
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desensitization: Active Comparator
mentation on insomnia behaviors and cognitive activity
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Behavioral: desensitization
mentation on insomnia behaviors and cognitive activity
|
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.
Ages Eligible for Study: | 21 Years to 59 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sat Bir S Khalsa, Ph.D. | (617) 732-7994 | khalsa@hms.harvard.edu |
United States, Massachusetts | |
Sleep Disorders Program, Brigham and Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Sat Bir S Khalsa, Ph.D. | Brigham and Women's Hospital, Harvard Medical School |
Responsible Party: | Brigham and Women's Hospital ( Sat Bir S. Khalsa ) |
Study ID Numbers: | R01 AT002490, R01 AT002490 |
Study First Received: | March 14, 2006 |
Last Updated: | March 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00303342 History of Changes |
Health Authority: | United States: Federal Government |
sleep arousal stress cortisol catecholamines |
Sleep Initiation and Maintenance Disorders Hydrocortisone Cortisol succinate Mental Disorders Dyssomnias |
Sleep Disorders Stress Hydrocortisone acetate Sleep Disorders, Intrinsic |
Sleep Initiation and Maintenance Disorders Mental Disorders Nervous System Diseases |
Sleep Disorders Dyssomnias Sleep Disorders, Intrinsic |