Status:
COMPLETED
Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea
Lead Sponsor:
Ventus Medical, Inc.
Conditions:
Obstructive Sleep Apnea Hypopnea
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate the long-term durability of the treatment and safety of the Provent device for those individuals who were enrolled in the C009 study, were diagnosed with obstr...
Eligibility Criteria
Inclusion
- Based upon scoring at the study site, the 3-month 'device on' PSG has a 50% reduction in AHI compared to the 1-week 'device off' PSG AHI OR the 3-month 'device on' PSG AHI \<10
- Used the Provent device at least 4 hours for at least 5/7 nights per week on average during months 1 and 2 of the three month C009 study
- The study physician and investigator believe that continued Provent use does not represent a significant safety risk for the patient
- Patient understands and is willing and able to comply with study requirements
Exclusion
- 1\. The patient must continue to not meet all of the exclusion criteria of protocol C009
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00849043
Start Date
February 1 2009
End Date
October 1 2010
Last Update
January 26 2011
Active Locations (13)
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1
Gaylord Sleep Medicine Research
Wallingford, Connecticut, United States, 06492
2
University of Florida Health Science Center
Gainesville, Florida, United States, 32610-0225
3
Sleep Disorders Center of Georgia
Atlanta, Georgia, United States, 30342
4
Suburban Lung Associates
Elk Grove Village, Illinois, United States, 60007