We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00303342
First Posted: March 16, 2006
Last Update Posted: January 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by:
Brigham and Women's Hospital
  Purpose
The purpose of this study is to evaluate the change in measures of physiological arousal before and after behavioral treatment of insomnia.

Condition Intervention Phase
Insomnia Behavioral: mind body treatment Behavioral: desensitization Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • plasma cortisol [ Time Frame: pretreatment, posttreatment ]
  • plasma melatonin [ Time Frame: pretreatment, posttreatment ]
  • urinary catecholamines [ Time Frame: pretreatment, posttreatment ]
  • heart rate variability [ Time Frame: pretreatment, posttreatment ]
  • subjective sleep efficiency [ Time Frame: pretreatment, during treatment, posttreatment, followup ]
  • objective sleep efficiency [ Time Frame: pretreatment, posttreatment ]

Secondary Outcome Measures:
  • actigraphy [ Time Frame: pretreatment, posttreatment ]
  • EEG [ Time Frame: pretreatment, posttreatment ]
  • subjective mood [ Time Frame: pretreatment, during treatment, posttreatment, followup ]
  • depression [ Time Frame: pretreatment, during treatment, posttreatment, followup ]
  • anxiety [ Time Frame: pretreatment, during treatment, posttreatment, followup ]

Estimated Enrollment: 60
Study Start Date: March 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00303342


Locations
United States, Massachusetts
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
  More Information

Responsible Party: Sat Bir S. Khalsa, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00303342     History of Changes
Other Study ID Numbers: R01AT002490 ( U.S. NIH Grant/Contract )
First Submitted: March 14, 2006
First Posted: March 16, 2006
Last Update Posted: January 14, 2010
Last Verified: January 2010

Keywords provided by Brigham and Women's Hospital:
sleep
arousal
stress
cortisol
catecholamines

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders