Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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mind body treatment

regulation of attention, respiration and posture

Group Type EXPERIMENTAL

mind body treatment

Intervention Type BEHAVIORAL

regulation of attention, respiration and posture

desensitization

mentation on insomnia behaviors and cognitive activity

Group Type ACTIVE_COMPARATOR

desensitization

Intervention Type BEHAVIORAL

mentation on insomnia behaviors and cognitive activity

Interventions

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mind body treatment

regulation of attention, respiration and posture

Intervention Type BEHAVIORAL

desensitization

mentation on insomnia behaviors and cognitive activity

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No