A Phase 2 interventional study of mind body treatment and desensitization in Insomnia, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 21 Years to 59 Years. Per ClinicalTrials.gov, last updated 2010-01-14.
Sponsored by Brigham and Women's Hospital · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the change in measures of physiological arousal before and after behavioral treatment of insomnia.
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.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's planned enrollment of 60 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
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Exclusion Criteria:
regulation of attention, respiration and posture
Behavioral: mind body treatment
mentation on insomnia behaviors and cognitive activity
Behavioral: desensitization
regulation of attention, respiration and posture
mentation on insomnia behaviors and cognitive activity
plasma cortisol
Time frame: pretreatment, posttreatment
plasma melatonin
Time frame: pretreatment, posttreatment
urinary catecholamines
Time frame: pretreatment, posttreatment
heart rate variability
Time frame: pretreatment, posttreatment
subjective sleep efficiency
Time frame: pretreatment, during treatment, posttreatment, followup
objective sleep efficiency
Time frame: pretreatment, posttreatment
actigraphy
Time frame: pretreatment, posttreatment
EEG
Time frame: pretreatment, posttreatment
subjective mood
Time frame: pretreatment, during treatment, posttreatment, followup
depression
Time frame: pretreatment, during treatment, posttreatment, followup
anxiety
Time frame: pretreatment, during treatment, posttreatment, followup
This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
Brigham and Women's Hospital