Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia

Official Title: “Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia”

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

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• plasma cortisol
  • Time Frame: pretreatment, posttreatment
    Safety Issue?: No
• plasma melatonin
  • Time Frame: pretreatment, posttreatment
    Safety Issue?: No
• urinary catecholamines
  • Time Frame: pretreatment, posttreatment
    Safety Issue?: No
• heart rate variability
  • Time Frame: pretreatment, posttreatment
    Safety Issue?: No
• subjective sleep efficiency
  • Time Frame: pretreatment, during treatment, posttreatment, followup
    Safety Issue?: No
• objective sleep efficiency
  • Time Frame: pretreatment, posttreatment
    Safety Issue?: No

Secondary Measures

• actigraphy
  • Time Frame: pretreatment, posttreatment
    Safety Issue?: No
• EEG
  • Time Frame: pretreatment, posttreatment
    Safety Issue?: No
• subjective mood
  • Time Frame: pretreatment, during treatment, posttreatment, followup
    Safety Issue?: No
• depression
  • Time Frame: pretreatment, during treatment, posttreatment, followup
    Safety Issue?: No
• anxiety
  • Time Frame: pretreatment, during treatment, posttreatment, followup
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 59 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Brigham and Women's Hospital Other

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00303342

Study ID Number: R01 AT002490

ClinicalTrials.gov Identifier: NCT00303342

Health Authority: United States: Federal Government