Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea
AERO C009E
A Single Arm, Open-label Extension Study to Evaluate the Long-term Durability of Treatment Response and and Safety of the Provent Professional Sleep Apnea Therapy Device for the Non-invasive Treatment of Obstructive Sleep Apnea-hypopnea
1 other identifier
observational
65
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2009
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 19, 2009
CompletedFirst Posted
Study publicly available on registry
February 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedJanuary 26, 2011
January 1, 2011
1.5 years
February 19, 2009
January 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Measurement of the subjects quality of life
12 months
Study Arms (1)
Provent
Provent Professional Sleep Apnea Therapy device
Eligibility Criteria
OSA subjects from C009 AERO study who were randomized to the Provent arm and completed the study. All must continue to meet the C009 inclusion and exclusion criteria.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Gaylord Sleep Medicine Research
Wallingford, Connecticut, 06492, United States
University of Florida Health Science Center
Gainesville, Florida, 32610-0225, United States
Sleep Disorders Center of Georgia
Atlanta, Georgia, 30342, United States
Suburban Lung Associates
Elk Grove Village, Illinois, 60007, United States
Kentucky Research Group
Louisville, Kentucky, 40217, United States
Sleep HealthCenters
Brighton, Massachusetts, 02135, United States
Wayne State University Harper Univ. Hospital
Detroit, Michigan, 48201, United States
Borgess Research
Kalamazoo, Michigan, 49024, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
St. Luke's Hospital Sleep Medicine & Research Center
Chesterfield, Missouri, 63001, United States
The Corvallis Clinic
Corvallis, Oregon, 97330, United States
Sleep Medicine Associates of Texas
Dallas, Texas, 75231, United States
Sleep Therapy and Research Center
San Antonio, Texas, 07829, United States
Related Publications (1)
Kryger MH, Berry RB, Massie CA. Long-term use of a nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA). J Clin Sleep Med. 2011 Oct 15;7(5):449-53B. doi: 10.5664/JCSM.1304.
PMID: 22003339DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meir Kryger, MD
Gaylord Sleep Medicine Research
Study Design
- Study Type
- observational
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 19, 2009
First Posted
February 23, 2009
Study Start
February 1, 2009
Primary Completion
August 1, 2010
Study Completion
October 1, 2010
Last Updated
January 26, 2011
Record last verified: 2011-01