Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia

Insomnia Clinical Trial

Official title:

Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00303342
• Other study ID #: R01AT002490
• Secondary ID: R01AT002490
• Status: Completed
• Phase: Phase 2
• First received: March 14, 2006
• Last updated: January 12, 2010
• Start date: March 2006
• Est. completion date: June 2009

Study information

• Verified date: January 2010
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 59 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Behavioral:
• mind body treatment
regulation of attention, respiration and posture
• desensitization
mentation on insomnia behaviors and cognitive activity

Locations

Country	Name	City	State
United States	Sleep Disorders Program, Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma cortisol		pretreatment, posttreatment	No
Primary	plasma melatonin		pretreatment, posttreatment	No
Primary	urinary catecholamines		pretreatment, posttreatment	No
Primary	heart rate variability		pretreatment, posttreatment	No
Primary	subjective sleep efficiency		pretreatment, during treatment, posttreatment, followup	No
Primary	objective sleep efficiency		pretreatment, posttreatment	No
Secondary	actigraphy		pretreatment, posttreatment	No
Secondary	EEG		pretreatment, posttreatment	No
Secondary	subjective mood		pretreatment, during treatment, posttreatment, followup	No
Secondary	depression		pretreatment, during treatment, posttreatment, followup	No
Secondary	anxiety		pretreatment, during treatment, posttreatment, followup	No