Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea

Completed

Conditions studied: Obstructive Sleep Apnea Hypopnea, Obstructive Sleep Apnea, OSAH

In brief

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 obstructive sleep apnea-hypopnea (OSAH), and were actively using the Provent device.

Key facts

Study ID

NCT00849043

Run by

Ventus Medical, Inc.

People needed

65

Starts

2009-02-01

Expected to finish

2010-10-01

Last updated by the study team

2011-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• The patient must continue to not meet all of the exclusion criteria of protocol C009

Where it is running

• Gaylord Sleep Medicine Research — Wallingford, Connecticut, United States
• University of Florida Health Science Center — Gainesville, Florida, United States
• Sleep Disorders Center of Georgia — Atlanta, Georgia, United States
• Suburban Lung Associates — Elk Grove Village, Illinois, United States
• Kentucky Research Group — Louisville, Kentucky, United States
• Sleep HealthCenters — Brighton, Massachusetts, United States
• Wayne State University Harper Univ. Hospital — Detroit, Michigan, United States
• Borgess Research — Kalamazoo, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• St. Luke's Hospital Sleep Medicine & Research Center — Chesterfield, Missouri, United States
• The Corvallis Clinic — Corvallis, Oregon, United States
• Sleep Medicine Associates of Texas — Dallas, Texas, United States
• Sleep Therapy and Research Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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