Sleep Homeostasis in Primary Insomnia Following Behavioral Treatment

This study has been completed.
Sponsor:
Collaborator:
American Academy of Sleep Medicine
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00256503
First received: November 16, 2005
Last updated: February 19, 2009
Last verified: February 2009
  Purpose

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
Behavioral: Cognitive-Behavioral Therapy for Insomnia

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sleep Homeostasis in Primary Insomnia Following Behavioral Treatment

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Mean sleep latency, % total recovery sleep time, and Slow Wave Sleep (SWS) and mean NREM delta power. [ Time Frame: November 2008 ] [ Designated as safety issue: No ]
  • SWS response to sleep deprivation, and cortical (Beta/Gamma power) and somatic arousal (cortisol). [ Time Frame: November 2008 ] [ Designated as safety issue: No ]
  • Sleep homeostasis, cortical arousal, and somatic arousal (at Phase 3) in PIs. [ Time Frame: November 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of circadian distribution of somatic (cortisol) and cortical (Beta/Gamma EEG) arousal in association with sleep deprivation. [ Time Frame: November 2008 ] [ Designated as safety issue: No ]
  • Evaluation of the 24-hour distribution of somatic (cortisol) and cortical (Beta/Gamma EEG) arousal in PIs. [ Time Frame: November 2008 ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: December 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Cognitive-Behavioral Therapy for Insomnia
    Insomnia Subjects receive CBT-I
    Other Name: Insomnia Subjects receive CBT-I
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256503

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
American Academy of Sleep Medicine
Investigators
Principal Investigator: Wilfred R. Pigeon, Ph.D. University of Rochester
Principal Investigator: Michael L. Perlis, Ph.D. University of Rochester
  More Information

Additional Information:
No publications provided

Responsible Party: Wilfred R. Pigeon, Ph.D./Primary Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT00256503     History of Changes
Other Study ID Numbers: 33-CA-05, 012331
Study First Received: November 16, 2005
Last Updated: February 19, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Primary Insomnia
Insomnia
Sleep

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014