About 10% of the population is believed to suffer from Primary Insomnia. It is also believed that people with chronic insomnia have a sleep system that is essentially out of alignment (we call this “homeostatic dysregulation”). We also know that a certain form of non-medication therapy called cognitive-behavioral therapy is a very effective treatment for insomnia. It is not known, however, whether cognitive-behavioral therapy actually works by bringing the brain’s sleep system back into alignment (“sleep homeostasis”). One of the methods used to measure sleep homeostasis is to observe a person’s brain waves during sleep and particularly during sleep that follows a period of sleep loss.

The purposes of this study are to first learn whether persons with insomnia do have a misaligned sleep system compared to persons who do not have insomnia by assessing the sleep of people before and after a period of extended sleep loss. Second, the study will determine whether cognitive-behavioral therapy can re-regulate the sleep system and its response to sleep loss. Third, the final purpose is to examine whether the immune system of people with insomnia is more altered following sleep loss than in the comparison group and whether cognitive-behavioral therapy can alter immune function.

Condition	Intervention
Primary Insomnia	Behavior: Cognitive-Behavioral Therapy for Insomnia

Further study details as provided by University of Rochester:

Primary Outcomes: 1. Mean sleep latency, % total recovery sleep time, and Slow Wave Sleep (SWS) and mean NREM delta power.; 2. SWS response to sleep deprivation, and cortical (Beta/Gamma power) and somatic arousal (cortisol).; 3. Sleep homeostasis, cortical arousal, and somatic arousal (at Phase 3) in PIs.
Secondary Outcomes: 1. Assessment of circadian distribution of somatic (cortisol) and cortical (Beta/Gamma EEG) arousal in association with sleep deprivation.; 2. Evaluation of the 24-hour distribution of somatic (cortisol) and cortical (Beta/Gamma EEG) arousal in PIs.
Expected Total Enrollment:  18

Despite the magnitude of the problem of Primary Insomnia, and the good efficacy of Cognitive Behavioral Treatment for Insomnia (CBT-I), little is known about the pathophysiology of insomnia or whether treatment alters the factors that are thought to maintain chronic insomnia. Three main factors have been explored as contributing to chronic insomnia: hyperarousal, circadian dysrhythmia, and homeostatic dysregulation. Most of the empirical work has been related to the role of hyperarousal along three dimensions: somatic, cognitive, and cortical.

The present study is focused on homeostatic abnormalities and secondarily on hyperarousal as exhibited in subjects with Primary Insomnia (PIs) compared to Good Sleeper controls (GSs). Homeostatic abnormalities will be assessed by evaluating how patients with insomnia respond to sleep deprivation.

This study will use a Modified Sleep Deprivation and Multiple Sleep Latency Test (MSD/MSLT) procedure. Response to the procedure will be assessed in terms of sleep continuity, sleep architecture and electroencephalographic (EEG) power spectral changes during recovery sleep. Hyperarousal will be evaluated using serial measures of somatic (cortisol) and cortical (EEG Beta/Gamma activity) arousal across the sleep deprivation protocol.

These parameters will be evaluated both prior to and following CBT-I in PIs and following an equivalent time interval in GSs.

Ages Eligible for Study:  25 Years   -   55 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

Primary Insomnia (PI) subjects:

• Difficulty falling or staying asleep for 6 or more months as evidenced by (a) 30 or more minutes to fall asleep on 3 or more nights per week, or (b) early morning awakenings > 30 minutes prior to desired rise time on 3 or more nights per week
• Reported impaired daytime function attributed to insomnia

Good-Sleeper (GS) controls:

• No history of sleep disorders
• No current sleep complaints and/or complaints of daytime fatigue or sleepiness
• Sleep characterized as restorative and relatively “unperturbable”; and will be defined as: 5-15 minutes to fall asleep and no more than two awakenings per night of > 5 minutes duration

Exclusion Criteria:

• Significant medical or psychiatric illness
• Diagnosed or occult sleep disorders (evident on screening PSG) other than PI
• Hearing or memory impairments
• Non-fluency in spoken or written English
• History of head injury (w/ loss of consciousness) or seizures
• Prescription medication or recreational drug use within 4 weeks of laboratory study
• Tobacco use or consume more than 3 cups of coffee per day (or an equivalent dose of caffeine)

Please refer to this study by ClinicalTrials.gov identifier  NCT00256503

Jeffrey Swan, M.A.      585-273-2571    Jeffrey_Swan@urmc.rochester.edu
Heather Kennedy, B.A.      585-275-2900    Heather_Kennedy@urmc.rochester.edu

New York
      University of Rochester Medical Center, Rochester,  New York,  14642,  United States

Study chairs or principal investigators

Wilfred R. Pigeon, Ph.D.,  Principal Investigator,  University of Rochester   
Michael L. Perlis, Ph.D.,  Principal Investigator,  University of Rochester   

Study ID Numbers:  33-CA-05; 012331
Last Updated:  December 8, 2005
Record first received:  November 16, 2005
ClinicalTrials.gov Identifier:  NCT00256503
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10