Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia

Phase 2

Completed

• Conditions: Insomnia
• Interventions: Behavioral: mind body treatment; Behavioral: desensitization

• Registration Number: NCT00303342
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-14
• Study First Submitted QC: 2006-03-14
• Study First Posted: 2006-03-16
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-12
• Last Update Posted: 2010-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mind body treatment	mind body treatment	regulation of attention, respiration and posture
desensitization	desensitization	mentation on insomnia behaviors and cognitive activity

Primary Outcome Measures

Name	Time	Method
heart rate variability	pretreatment, posttreatment
plasma cortisol	pretreatment, posttreatment
plasma melatonin	pretreatment, posttreatment
subjective sleep efficiency	pretreatment, during treatment, posttreatment, followup
urinary catecholamines	pretreatment, posttreatment
objective sleep efficiency	pretreatment, posttreatment

Secondary Outcome Measures

Name	Time	Method
EEG	pretreatment, posttreatment
subjective mood	pretreatment, during treatment, posttreatment, followup
depression	pretreatment, during treatment, posttreatment, followup
anxiety	pretreatment, during treatment, posttreatment, followup
actigraphy	pretreatment, posttreatment

Trial Locations

Locations (1)

Sleep Disorders Program, Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States