Sleep Homeostasis in Primary Insomnia

Sleep Homeostasis in Primary Insomnia Following Behavioral Treatment

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.

Study Overview

• Status: Completed
• Conditions: Primary Insomnia
• Intervention / Treatment: Behavioral: Cognitive-Behavioral Therapy for Insomnia

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Insomnia Subjects receive CBT-I
No Intervention: Good Sleeper; Good sleeper controls who receive no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Slow Wave Sleep (SWS)	Mean minutes of slow wave sleep as measured by standard sleep stage scoring	Baseline to end of Study (up to 12 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delta Power	Mean relative power of delta frequency activity during sleep as measured by power spectral analysis	Baseline to end of study (up to 12 weeks)

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: November 16, 2005
• First Submitted That Met QC Criteria: November 16, 2005
• First Posted (Estimate): November 21, 2005

Study Record Updates

• Last Update Posted (Estimate): January 12, 2016
• Last Update Submitted That Met QC Criteria: January 11, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Sleep; Insomnia; Primary Insomnia
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 33-CA-05; 012331 (Other Grant/Funding Number: American Sleep Medicine Foundation)