Safety and Efficacy of an Ambulatory Biofeedback Device for Primary Insomnia
NCT00415714 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132
Last updated 2007-01-29
Summary
The objective of this study is to determine the efficacy of a portable biofeedback device on improving sleep latency and other sleep variables such as nocturnal awake time and daytime functioning in persons with primary insomnia.
Conditions
- Primary Insomnia
Interventions
- DEVICE
-
Portable Biofeedback
Sponsors & Collaborators
-
Helicor
lead INDUSTRY
Principal Investigators
-
Jack Edinger, Ph.D. · Duke Unversity Medical Center
-
Charles Morin, Ph.D. · University of Laval
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-09-30
- Completion
- 2007-10-31
Countries
- United States
Study Locations
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