Sleep Disorders Program, Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
NCT Number: NCT00303342
The purpose of this study is to evaluate the change in measures of physiological arousal before and after behavioral treatment of insomnia.
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Notify Me21 year–59 year
All sexes
Interventional
Phase 2
Boston, Massachusetts, 02115, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
regulation of attention, respiration and posture
mentation on insomnia behaviors and cognitive activity
Time frame: pretreatment, posttreatment
Time frame: pretreatment, posttreatment
Time frame: pretreatment, posttreatment
Time frame: pretreatment, posttreatment
Time frame: pretreatment, during treatment, posttreatment, followup
Time frame: pretreatment, posttreatment
Time frame: pretreatment, posttreatment
Time frame: pretreatment, posttreatment
Time frame: pretreatment, during treatment, posttreatment, followup
Time frame: pretreatment, during treatment, posttreatment, followup
Time frame: pretreatment, during treatment, posttreatment, followup
Brigham and Women's Hospital
Other
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