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Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia

Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00303342
Enrollment
60
Registered
2006-03-16
Start date
2006-03-31
Completion date
2009-06-30
Last updated
2010-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

sleep, arousal, stress, cortisol, catecholamines

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.

Interventions

BEHAVIORALmind body treatment

regulation of attention, respiration and posture

BEHAVIORALdesensitization

mentation on insomnia behaviors and cognitive activity

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 59 Years
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

* 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

Design outcomes

Primary

MeasureTime frame
objective sleep efficiencypretreatment, posttreatment
plasma cortisolpretreatment, posttreatment
plasma melatoninpretreatment, posttreatment
urinary catecholaminespretreatment, posttreatment
heart rate variabilitypretreatment, posttreatment
subjective sleep efficiencypretreatment, during treatment, posttreatment, followup

Secondary

MeasureTime frame
EEGpretreatment, posttreatment
subjective moodpretreatment, during treatment, posttreatment, followup
depressionpretreatment, during treatment, posttreatment, followup
anxietypretreatment, during treatment, posttreatment, followup
actigraphypretreatment, posttreatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026