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Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia

Primary Purpose

Insomnia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
mind body treatment
desensitization
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring sleep, arousal, stress, cortisol, catecholamines

Eligibility Criteria

21 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sleep Disorders Program, Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mind body treatment

desensitization

Arm Description

regulation of attention, respiration and posture

mentation on insomnia behaviors and cognitive activity

Outcomes

Primary Outcome Measures

plasma cortisol
plasma melatonin
urinary catecholamines
heart rate variability
subjective sleep efficiency
objective sleep efficiency

Secondary Outcome Measures

actigraphy
EEG
subjective mood
depression
anxiety

Full Information

First Posted
March 14, 2006
Last Updated
January 12, 2010
Sponsor
Brigham and Women's Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00303342
Brief Title
Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia
Official Title
Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
sleep, arousal, stress, cortisol, catecholamines

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mind body treatment
Arm Type
Experimental
Arm Description
regulation of attention, respiration and posture
Arm Title
desensitization
Arm Type
Active Comparator
Arm Description
mentation on insomnia behaviors and cognitive activity
Intervention Type
Behavioral
Intervention Name(s)
mind body treatment
Intervention Description
regulation of attention, respiration and posture
Intervention Type
Behavioral
Intervention Name(s)
desensitization
Intervention Description
mentation on insomnia behaviors and cognitive activity
Primary Outcome Measure Information:
Title
plasma cortisol
Time Frame
pretreatment, posttreatment
Title
plasma melatonin
Time Frame
pretreatment, posttreatment
Title
urinary catecholamines
Time Frame
pretreatment, posttreatment
Title
heart rate variability
Time Frame
pretreatment, posttreatment
Title
subjective sleep efficiency
Time Frame
pretreatment, during treatment, posttreatment, followup
Title
objective sleep efficiency
Time Frame
pretreatment, posttreatment
Secondary Outcome Measure Information:
Title
actigraphy
Time Frame
pretreatment, posttreatment
Title
EEG
Time Frame
pretreatment, posttreatment
Title
subjective mood
Time Frame
pretreatment, during treatment, posttreatment, followup
Title
depression
Time Frame
pretreatment, during treatment, posttreatment, followup
Title
anxiety
Time Frame
pretreatment, during treatment, posttreatment, followup

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sat Bir S Khalsa, Ph.D.
Organizational Affiliation
Brigham and Women's Hospital, Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Disorders Program, Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia

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