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Sponsored by: |
Helicor |
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Information provided by: | Helicor |
ClinicalTrials.gov Identifier: | NCT00415714 |
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.
Condition | Intervention |
---|---|
Primary Insomnia |
Device: Portable Biofeedback |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Controlled Pilot Trial Testing the Safety and Efficacy of an Ambulatory Biofeedback Device for Primary Insomnia |
Estimated Enrollment: | 132 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | October 2007 |
There is evidence that when compared to normal controls, persons with insomnia exhibit increased cognitive and physiological arousal and higher overall metabolic rate during sleep, particularly at sleep onset. There is evidence that reducing this arousal may impact sleep latency and nocturnal awake time. Although relaxation treatments have been integrated into behavioral therapies, there are numerous barriers to their implementation in real world settings. The present study is designed to examine the effect of a portable biofeedback device designed to induce physiological relaxation as compared to an inactive sham control device condition in reducing sleep onset latency in persons with primary insomnia over a 4 week period at three separate research sites.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Met DSM-IV-TR criteria for Primary Insomnia as measured by the:
Exclusion Criteria:
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Jack Edinger, Ph.D. 919-681-8392 jack.edinger@duke.edu |
Principal Investigator: | Jack Edinger, Ph.D. | Duke Unversity Medical Center |
Principal Investigator: | Charles Morin, Ph.D. | University of Laval |
Study ID Numbers: | H300 |
Study First Received: | December 21, 2006 |
Last Updated: | January 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00415714 |
Health Authority: | United States: Institutional Review Board |
Primary Insomnia Chronic Insomnia Biofeedback Sleeplessness |
Sleep Initiation and Maintenance Disorders Mental Disorders Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic |
Nervous System Diseases |