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Sleep Homeostasis in Primary Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00256503
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : January 12, 2016
American Academy of Sleep Medicine
Information provided by (Responsible Party):
Wilfred Pigeon, PhD, University of Rochester

Brief Summary:

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 or disease Intervention/treatment Phase
Primary Insomnia Behavioral: Cognitive-Behavioral Therapy for Insomnia Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sleep Homeostasis in Primary Insomnia Following Behavioral Treatment
Study Start Date : December 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: Insomnia
Insomnia subjects who receive 8 session cognitive behavioral therapy for insomnia.
Behavioral: Cognitive-Behavioral Therapy for Insomnia
Insomnia Subjects receive CBT-I
Other Name: Insomnia Subjects receive CBT-I

No Intervention: Good Sleeper
Good sleeper controls who receive no intervention

Primary Outcome Measures :
  1. Slow Wave Sleep (SWS) [ Time Frame: Baseline to end of Study (up to 12 weeks) ]
    Mean minutes of slow wave sleep as measured by standard sleep stage scoring

Secondary Outcome Measures :
  1. Delta Power [ Time Frame: Baseline to end of study (up to 12 weeks) ]
    Mean relative power of delta frequency activity during sleep as measured by power spectral analysis

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00256503

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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
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Principal Investigator: Wilfred R. Pigeon, Ph.D. University of Rochester
Principal Investigator: Michael L. Perlis, Ph.D. University of Rochester
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Responsible Party: Wilfred Pigeon, PhD, Associate Professor, University of Rochester Identifier: NCT00256503    
Other Study ID Numbers: 33-CA-05
012331 ( Other Grant/Funding Number: American Sleep Medicine Foundation )
First Posted: November 21, 2005    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016
Keywords provided by Wilfred Pigeon, PhD, University of Rochester:
Primary Insomnia
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders