Status:
COMPLETED
Sleep Homeostasis in Primary Insomnia
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
American Academy of Sleep Medicine
Conditions:
Primary Insomnia
Eligibility:
All Genders
25-55 years
Phase:
NA
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 "h...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00256503
Start Date
December 1 2005
End Date
December 1 2008
Last Update
January 12 2016
Active Locations (1)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642