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Sponsored by: |
Ventus Medical, Inc. |
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Information provided by: | Ventus Medical, Inc. |
ClinicalTrials.gov Identifier: | NCT00772044 |
Primary Endpoints:
•Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine)
Secondary Endpoints: By polysomnography, reduction in:
Patient acceptance, in terms of:
Condition | Intervention | Phase |
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Obstructive Sleep Apnea Hypopnea OSA OSAH |
Device: Provent Professional Sleep Apnea Therapy Device Device: Sham Device |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind Study to Compare Safety and Effectiveness of the ProventTM Professional Sleep Apnea Therapy Device to Sham for the Non-Invasive Treatment of OSAH |
Estimated Enrollment: | 250 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Provent: Active Comparator
Those receiving the active device
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Device: Provent Professional Sleep Apnea Therapy Device
Application of active device (Provent)
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Sham: Sham Comparator
Those receiving sham device
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Device: Sham Device
Sham device will be applied
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Please see summary above
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Stanford University Center of Excellence for Sleep Disorder | Not yet recruiting |
Stanford, California, United States, 94305 | |
Contact: Chia-Yu Cardell 650-725-1915 ccardell@stanford.edu | |
Principal Investigator: Clete Kushida, M.D. | |
United States, Connecticut | |
Gaylord Sleep Medicine | Recruiting |
Wallingford, Connecticut, United States, 06492 | |
Contact: Valerie Assalone 203-741-3411 vassalone@gaylord.org | |
Principal Investigator: Meir Kryger, M.D. | |
United States, Florida | |
University Of Florida College of Medicine | Recruiting |
Gainesville, Florida, United States, 32610 | |
Contact: Susan Purdy 352-371-1735 susan.purdy@medicine.ufl.edu | |
Principal Investigator: Richard B Berry, M.D. | |
United States, Illinois | |
Chicago Sleep Group of Suburban Lung Associates | Recruiting |
Elk Grove Village, Illinois, United States, 60007 | |
Contact: Judy Goodman 847-981-3660 judy.goodman@sublung.com | |
Principal Investigator: Clifford Massie, PhD | |
United States, Massachusetts | |
Neurocare, Inc. Center for Sleep Diagnostics | Recruiting |
Newton, Massachusetts, United States, 02459 | |
Contact: Jodi Larkin 617-581-6416 jlarkin@neurocareinc.com | |
Principal Investigator: Michael Biber, M.D. | |
Sleep Health Center | Recruiting |
Brighton, Massachusetts, United States, 02135 | |
Contact: Melissa Maywalt 617-783-1441 ext 136 Melissa_Maywalt@sleephealth.com | |
Principal Investigator: Doug Kirsch, M.D. | |
United States, Michigan | |
Wayne State University | Recruiting |
Detroit, Michigan, United States, 48201 | |
Contact: Roze Kadri 313-745-2361 rkadri@med.wayne.edu | |
Principal Investigator: M. Safwan Badr, M.D. | |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Courtney Frerichs 507-255-1997 Frerichs.Courtney@mayo.edu | |
Principal Investigator: Sean Caples, D.O. | |
United States, Missouri | |
Sleep Medicine and Research Center | Recruiting |
Chesterfield, Missouri, United States, 63017 | |
Contact: Nancy Cline 314-205-6325 nancy.cline@stlukes_stl.com | |
Principal Investigator: Paula Schweitzer, PhD | |
United States, Oregon | |
The Corvallis Clinic | Recruiting |
Corvallis, Oregon, United States, 97330 | |
Contact: Julie Carrico 541-754-1275 Julie.carrico@corvallisclinic.com | |
Principal Investigator: Mark Reploeg, M.D. | |
United States, Texas | |
Sleep Medicine Associates of Texas | Recruiting |
Dallas, Texas, United States, 75231 | |
Contact: Linda Bradshaw 214-750-7776 lbradshaw@sleepmed.com | |
Principal Investigator: Leon Rosenthal, M.D. | |
United States, Washington | |
Kathryn Severyns Dement Sleep Disorder Center | Not yet recruiting |
Walla Walla, Washington, United States, 99362 | |
Contact: Kevin Hurlburt 509-525-3320 hurlke@smmc.com | |
Principal Investigator: Richard Simon, M.D. |
Principal Investigator: | Richard B Berry, M.D. | University of Florida College of Medicine |
Study Director: | Connie A Rey | Ventus Medical |
Responsible Party: | Ventus Medical, Inc. ( Connie Rey, Director, Clinical Affairs ) |
Study ID Numbers: | C009 |
Study First Received: | October 13, 2008 |
Last Updated: | December 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00772044 |
Health Authority: | United States: Institutional Review Board |
OSA sleep apnea apnea AHI |
Sleep Apnea Syndromes Apnea Clotrimazole Miconazole Sleep Apnea, Obstructive Respiration Disorders Tioconazole |
Sleep Disorders Dyssomnias Sleep Disorders, Intrinsic Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms, Respiratory Salicylhydroxamic acid |
Trypanocidal Agents Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents |
Therapeutic Uses Antifungal Agents Nervous System Diseases Pharmacologic Actions |