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

Completed

• Conditions: OSAH; Obstructive Sleep Apnea Hypopnea; Obstructive Sleep Apnea

• Registration Number: NCT00849043
• Lead Sponsor: Ventus Medical, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-19
• Study First Submitted QC: 2009-02-20
• Study First Posted: 2009-02-23
• Primary Completion: 2010-08
• Study Completion: 2010-10
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-25
• Last Update Posted: 2011-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1. 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
2. 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
3. The study physician and investigator believe that continued Provent use does not represent a significant safety risk for the patient
4. Patient understands and is willing and able to comply with study requirements

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure the percent change in the subject's apnea-hypopnea index (AHI) during the 12 month PSG while wearing the Provent device as compared to their AHI during the first week PSG when the subject did not wear the Provent device in the C009 study	12 months

Secondary Outcome Measures

Name	Time	Method
Measurement of the subjects quality of life	12 months

Trial Locations

Locations (13)

Suburban Lung Associates; 🇺🇸 Elk Grove Village, Illinois, United States

Borgess Research; 🇺🇸 Kalamazoo, Michigan, United States

Sleep HealthCenters; 🇺🇸 Brighton, Massachusetts, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Sleep Disorders Center of Georgia; 🇺🇸 Atlanta, Georgia, United States

Wayne State University Harper Univ. Hospital; 🇺🇸 Detroit, Michigan, United States

Sleep Therapy and Research Center; 🇺🇸 San Antonio, Texas, United States

Kentucky Research Group; 🇺🇸 Louisville, Kentucky, United States

Gaylord Sleep Medicine Research; 🇺🇸 Wallingford, Connecticut, United States

University of Florida Health Science Center; 🇺🇸 Gainesville, Florida, United States

The Corvallis Clinic; 🇺🇸 Corvallis, Oregon, United States

St. Luke's Hospital Sleep Medicine & Research Center; 🇺🇸 Chesterfield, Missouri, United States

Sleep Medicine Associates of Texas; 🇺🇸 Dallas, Texas, United States