Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00303342
• Collaborator: National Center for Complementary and Integrative Health (NCCIH) (NIH)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 39
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Behavioral: mind body treatment; Behavioral: desensitization	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia
• Study Start Date: Mar 1, 2006
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mind body treatment regulation of attention, respiration and posture	Behavioral: mind body treatment; regulation of attention, respiration and posture
Active Comparator: desensitization mentation on insomnia behaviors and cognitive activity	Behavioral: desensitization; mentation on insomnia behaviors and cognitive activity

Outcome Measures

Primary Outcome Measures

1. plasma cortisol [pretreatment, posttreatment]

2. plasma melatonin [pretreatment, posttreatment]

3. urinary catecholamines [pretreatment, posttreatment]

4. heart rate variability [pretreatment, posttreatment]

5. subjective sleep efficiency [pretreatment, during treatment, posttreatment, followup]

6. objective sleep efficiency [pretreatment, posttreatment]

Secondary Outcome Measures

1. actigraphy [pretreatment, posttreatment]

2. EEG [pretreatment, posttreatment]

3. subjective mood [pretreatment, during treatment, posttreatment, followup]

4. depression [pretreatment, during treatment, posttreatment, followup]

5. anxiety [pretreatment, during treatment, posttreatment, followup]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 59 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sleep Disorders Program, Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital
• National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Sat Bir S Khalsa, Ph.D., Brigham and Women's Hospital, Harvard Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00303342
• Other Study ID Numbers: R01AT002490; R01AT002490
• First Posted: Mar 16, 2006
• Last Update Posted: Jan 14, 2010
• Last Verified: Jan 1, 2010

• Keywords provided by , ,: sleep; arousal; stress; cortisol; catecholamines
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Jan 14, 2010