Clinical trial NCT00303342: Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia
Official title: Neuroendocrine Mechanisms in Behavioral Treatment of Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insomnia
Keywords: sleep
arousal
stress
cortisol
catecholamines
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2006-03-16
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: plasma cortisol
timeFrame: pretreatment, posttreatment
measure: plasma melatonin
timeFrame: pretreatment, posttreatment
measure: urinary catecholamines
timeFrame: pretreatment, posttreatment
measure: heart rate variability
timeFrame: pretreatment, posttreatment
measure: subjective sleep efficiency
timeFrame: pretreatment, during treatment, posttreatment, followup
measure: objective sleep efficiency
timeFrame: pretreatment, posttreatment
Secondary outcomes:
measure: actigraphy
timeFrame: pretreatment, posttreatment
measure: EEG
timeFrame: pretreatment, posttreatment
measure: subjective mood
timeFrame: pretreatment, during treatment, posttreatment, followup
measure: depression
timeFrame: pretreatment, during treatment, posttreatment, followup
measure: anxiety
timeFrame: pretreatment, during treatment, posttreatment, followup
Other outcomes:
Locations:
city: Boston
country: United States
facility: Sleep Disorders Program, Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital, Harvard Medical School
name: Sat Bir S Khalsa, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: