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CompletedNCT00303342Updated Jan 14, 2010

Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia

A Phase 2 interventional study of mind body treatment and desensitization in Insomnia, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 21 Years to 59 Years. Per ClinicalTrials.gov, last updated 2010-01-14.

Sponsored by Brigham and Women's Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
21 Years to 59 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Insomnia

Keywords

  • sleep
  • arousal
  • stress
  • cortisol
  • catecholamines
03

In context

Sleep Initiation and Maintenance Disorders

1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.

This study's planned enrollment of 60 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 59 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    mind body treatment

    regulation of attention, respiration and posture

    Behavioral: mind body treatment

  • Active comparator
    desensitization

    mentation on insomnia behaviors and cognitive activity

    Behavioral: desensitization

Interventions

  • Behavioralmind body treatment

    regulation of attention, respiration and posture

  • Behavioraldesensitization

    mentation on insomnia behaviors and cognitive activity

06

What researchers measure

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

07

Study locations

1 site
  • Sleep Disorders Program, Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00303342
Lead sponsor
Brigham and Women's Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
First posted
Mar 16, 2006
Start date
Mar 2006
Primary completion
Jun 2009
Completion
Jun 2009
Last update
Jan 14, 2010

Study contacts

Sat Bir S Khalsa, Ph.D.
principal investigator · Brigham and Women's Hospital, Harvard Medical School

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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