Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia - Full Text View

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00303342

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 II

Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

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
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
mind body treatment: Experimental regulation of attention, respiration and posture	Behavioral: mind body treatment regulation of attention, respiration and posture
desensitization: Active Comparator 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303342

Contacts

Contact: Sat Bir S Khalsa, Ph.D.

(617) 732-7994

khalsa@hms.harvard.edu

Locations

United States, Massachusetts
Sleep Disorders Program, Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Sat Bir S Khalsa, Ph.D.

Brigham and Women's Hospital, Harvard Medical School

More Information

Responsible Party:	Brigham and Women's Hospital ( Sat Bir S. Khalsa )
Study ID Numbers:	R01 AT002490, R01 AT002490
Study First Received:	March 14, 2006
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00303342
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

sleep
arousal
stress
cortisol
catecholamines

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Hydrocortisone
Cortisol succinate
Mental Disorders
Dyssomnias

Sleep Disorders
Stress
Hydrocortisone acetate
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009