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Combined Behavioral/Pharmacological Therapy for Insomnia - NCT00044629-27710(Clinical Trial 114646)



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City:  Durham
State:  
NC
Zip Code: 27710
Conditions: Sleep Initiation and Maintenance Disorders
Purpose: This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.
Study summary: Long-term insomnia is a common and significant health problem. Two main treatments, pharmacotherapy and behavioral therapy, have been used to help people with insomnia. Because both treatments have advantages and disadvantages, a combination of these treatments may be a good way to treat insomnia. During the first 2 weeks of the study, participants keep a sleep log, wear an actigraph (a device that resembles a wristwatch and records activity to help determine when participants are asleep or awake), and complete questionnaires. Participants are then randomly assigned to receive 6 weeks of behavioral therapy plus zolpidem tartrate (Ambien), behavioral therapy plus placebo, or behavioral therapy alone. During treatment, participants return to the clinic once a week to turn in their sleep logs, download their actigraph, and complete questionnaires. After 6 weeks, participants enter the post-treatment phase of the study, which lasts 2 weeks and is identical to the 2-week assessment at the beginning of the study. After the post-treatment phase, participants enter the follow-up period and are contacted at 3 months, 6 months, and 1 year to complete another 2-week assessment with sleep logs, actigraphy, and questionnaires.
Criteria: Inclusion Criteria: - Chronic primary insomnia which includes at least 6 months of trouble falling asleep or staying asleep
Study is available at: Duke Sleep Disorders Center
Durham, NC 27710
United States

Primary Contact:
William K Wohlgemuth, Ph.D.
Email: wkw@geri.duke.edu
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 21, 2011
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