Status:
COMPLETED
Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Conditions:
Insomnia
Insomnia Chronic
Eligibility:
All Genders
40-85 years
Phase:
PHASE4
Brief Summary
The study is a three phase sequential study of the medical treatment of insomnia with zolpidem. All participating subjects will receive one month of standard nightly treatment. If the subject has a po...
Detailed Description
Phase-1: Initial Evaluation. This evaluation occurs at the offices of the Behavioral Sleep Medicine Program (Suite 670, 3535 Market Street Philadelphia, PA 19104) and lasts about 1 to 2 hours. Proced...
Eligibility Criteria
Inclusion
- Meet DSM-5 criteria for Insomnia Disorder, ICSD-3, and RDC criteria for Psychophysiologic Insomnia
- Age 40-85
Exclusion
- currently in treatment for insomnia
- unstable medical or psychiatric illness
- a history of treatment failure with zolpidem
- discontinuation of zolpidem owing to side effects
- current experience, or history, of parasomnias (within the last 5 years)
Key Trial Info
Start Date :
April 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT03774810
Start Date
April 15 2019
End Date
September 30 2024
Last Update
May 9 2025
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104