Status:
UNKNOWN
A Treatment Study Comparing Two Non-Drug, Self-Help Treatment of Chronic Insomnia.
Lead Sponsor:
PICS, Inc.
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Insomnia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether a handheld computer is superior to a self-help manual for the treatment of chronic primary insomnia.
Detailed Description
Chronic primary insomnia is a highly prevalent condition, affecting up to 15% of the population. The condition is associated with daytime fatigue, lack of concentration, and decreased quality of life....
Eligibility Criteria
Inclusion
- sleep less than 6.5 hours per night
- at least 30 minutes of sleep onset latency or wakefulness after sleep onset
- symptoms present for at least 6 months
- must have insomnia symptoms at least 3 days per week
Exclusion
- Body Mass Index greater than 32
- Presence of anxiety disorder
- Secondary forms of insomnia
- Presence of a substance use disorder
- Concurrent treatment for another mental disorder
- History of other sleep disorders, including: apnea, restless legs, periodic limb movement disorder, or narcolepsy
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00310284
Start Date
January 1 2006
Last Update
April 3 2006
Active Locations (1)
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1
PICS, Inc.
Reston, Virginia, United States, 20191