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Completed

NCT Number: NCT00303342

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.

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Key information

Age range

21 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sleep Disorders Program, Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mind body treatment

Behavioral

regulation of attention, respiration and posture

desensitization

Behavioral

mentation on insomnia behaviors and cognitive activity

Primary outcomes

  1. plasma cortisol

    Time frame: pretreatment, posttreatment

  2. plasma melatonin

    Time frame: pretreatment, posttreatment

  3. urinary catecholamines

    Time frame: pretreatment, posttreatment

  4. heart rate variability

    Time frame: pretreatment, posttreatment

  5. subjective sleep efficiency

    Time frame: pretreatment, during treatment, posttreatment, followup

  6. objective sleep efficiency

    Time frame: pretreatment, posttreatment

Secondary outcomes

  1. actigraphy

    Time frame: pretreatment, posttreatment

  2. EEG

    Time frame: pretreatment, posttreatment

  3. subjective mood

    Time frame: pretreatment, during treatment, posttreatment, followup

  4. depression

    Time frame: pretreatment, during treatment, posttreatment, followup

  5. anxiety

    Time frame: pretreatment, during treatment, posttreatment, followup

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Mar 16, 2006
Registry last updated
Jan 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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