search
Back to results

Sleep Homeostasis in Primary Insomnia

Primary Purpose

Primary Insomnia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Therapy for Insomnia
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Insomnia focused on measuring Primary Insomnia, Insomnia, Sleep

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Rochester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Insomnia

Good Sleeper

Arm Description

Insomnia subjects who receive 8 session cognitive behavioral therapy for insomnia.

Good sleeper controls who receive no intervention

Outcomes

Primary Outcome Measures

Slow Wave Sleep (SWS)
Mean minutes of slow wave sleep as measured by standard sleep stage scoring

Secondary Outcome Measures

Delta Power
Mean relative power of delta frequency activity during sleep as measured by power spectral analysis

Full Information

First Posted
November 16, 2005
Last Updated
January 11, 2016
Sponsor
University of Rochester
Collaborators
American Academy of Sleep Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT00256503
Brief Title
Sleep Homeostasis in Primary Insomnia
Official Title
Sleep Homeostasis in Primary Insomnia Following Behavioral Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
American Academy of Sleep Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia
Keywords
Primary Insomnia, Insomnia, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insomnia
Arm Type
Experimental
Arm Description
Insomnia subjects who receive 8 session cognitive behavioral therapy for insomnia.
Arm Title
Good Sleeper
Arm Type
No Intervention
Arm Description
Good sleeper controls who receive no intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy for Insomnia
Other Intervention Name(s)
Insomnia Subjects receive CBT-I
Intervention Description
Insomnia Subjects receive CBT-I
Primary Outcome Measure Information:
Title
Slow Wave Sleep (SWS)
Description
Mean minutes of slow wave sleep as measured by standard sleep stage scoring
Time Frame
Baseline to end of Study (up to 12 weeks)
Secondary Outcome Measure Information:
Title
Delta Power
Description
Mean relative power of delta frequency activity during sleep as measured by power spectral analysis
Time Frame
Baseline to end of study (up to 12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfred R. Pigeon, Ph.D.
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael L. Perlis, Ph.D.
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Sleep Homeostasis in Primary Insomnia

We'll reach out to this number within 24 hrs