Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00303342
First received: March 14, 2006
Last updated: January 12, 2010
Last verified: January 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • plasma cortisol [ Time Frame: pretreatment, posttreatment ] [ Designated as safety issue: No ]
  • plasma melatonin [ Time Frame: pretreatment, posttreatment ] [ Designated as safety issue: No ]
  • urinary catecholamines [ Time Frame: pretreatment, posttreatment ] [ Designated as safety issue: No ]
  • heart rate variability [ Time Frame: pretreatment, posttreatment ] [ Designated as safety issue: No ]
  • subjective sleep efficiency [ Time Frame: pretreatment, during treatment, posttreatment, followup ] [ Designated as safety issue: No ]
  • objective sleep efficiency [ Time Frame: pretreatment, posttreatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • actigraphy [ Time Frame: pretreatment, posttreatment ] [ Designated as safety issue: No ]
  • EEG [ Time Frame: pretreatment, posttreatment ] [ Designated as safety issue: No ]
  • subjective mood [ Time Frame: pretreatment, during treatment, posttreatment, followup ] [ Designated as safety issue: No ]
  • depression [ Time Frame: pretreatment, during treatment, posttreatment, followup ] [ Designated as safety issue: No ]
  • anxiety [ Time Frame: pretreatment, during treatment, posttreatment, followup ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years to 59 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Sat Bir S Khalsa, Ph.D. Brigham and Women's Hospital, Harvard Medical School
  More Information

No publications provided

Responsible Party: Sat Bir S. Khalsa, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00303342     History of Changes
Other Study ID Numbers: R01 AT002490, R01AT002490, R01 AT002490
Study First Received: March 14, 2006
Last Updated: January 12, 2010
Health Authority: United States: Federal Government

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 Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on July 31, 2014