Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia

Study Overview
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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.

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.

Official Title
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Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: mind body treatment
* Behavioral: desensitization


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mind body treatment<br>regulation of attention, respiration and posture | Behavioral: mind body treatment<br>* regulation of attention, respiration and posture<br>|
| Active Comparator: desensitization<br>mentation on insomnia behaviors and cognitive activity | Behavioral: desensitization<br>* mentation on insomnia behaviors and cognitive activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma cortisol |  | pretreatment, posttreatment | 
| plasma melatonin |  | pretreatment, posttreatment | 
| urinary catecholamines |  | pretreatment, posttreatment | 
| heart rate variability |  | pretreatment, posttreatment | 
| subjective sleep efficiency |  | pretreatment, during treatment, posttreatment, followup | 
| objective sleep efficiency |  | pretreatment, posttreatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| actigraphy |  | pretreatment, posttreatment | 
| EEG |  | pretreatment, posttreatment | 
| subjective mood |  | pretreatment, during treatment, posttreatment, followup | 
| depression |  | pretreatment, during treatment, posttreatment, followup | 
| anxiety |  | pretreatment, during treatment, posttreatment, followup | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep, arousal, stress, cortisol, catecholamines