Sleep Disorders |
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Clinical Trial: Combined Behavioral/Pharmacological Therapy for Insomnia
This study is currently recruiting patients.
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Purpose
The purpose of this study is to determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.
| Condition | Treatment or Intervention |
|---|---|
| Sleep Initiation and Maintenance Disorders Sleep Deprivation | Behavior: Cognitive-Behavioral Therapy for Insomnia Drug: zolpidem tartrate (Ambien) |
MedlinePlus related topics: Sleep Disorders
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Expected Total Enrollment: 144
Study start: September 2001; Expected completion: August 2006
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.
Eligibility
Ages Eligible for Study: 21 Years - 75 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Chronic primary insomnia which includes at least 6 months of trouble falling asleep or staying asleep
Location and Contact Information
North Carolina
Duke Sleep Disorders Center, Durham, North Carolina, 27710, United States; Recruiting
Victoria Herring 919-681-8392
William K Wohlgemuth, Ph.D., Principal Investigator
Andrew Krystal, M.D., Sub-Investigator
Jack D Edinger, Ph.D., Sub-Investigator
More Information
Record last reviewed: October 2004
Last Updated: October 13, 2004
Record first received: September 3, 2002
ClinicalTrials.gov Identifier: NCT00044629
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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