Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea (AERO C009E)

Tracking Information
First Submitted Date	February 19, 2009
First Posted Date	February 23, 2009
Last Update Posted Date	January 26, 2011
Study Start Date	February 2009
Actual Primary Completion Date	August 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: February 26, 2009)	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 [ Time Frame: 12 months ]
Original Primary Outcome Measures; (submitted: February 20, 2009)	To measure the percent change in the subject's apnea-hyopnea 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 [ Time Frame: 12 months ]
Change History	Complete list of historical versions of study NCT00849043 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: February 20, 2009)	Measurement of the subjects quality of life [ Time Frame: 12 months ]
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea
Official Title	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
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 Provided
Study Type	Observational
Study Design	Not Provided
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	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.
Condition	Obstructive Sleep Apnea Hypopnea; Obstructive Sleep Apnea; OSAH
Intervention	Not Provided
Study Groups/Cohorts	Provent; Provent Professional Sleep Apnea Therapy device
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Estimated Enrollment; (submitted: February 20, 2009)	65
Original Estimated Enrollment	Same as current
Actual Study Completion Date	October 2010
Actual Primary Completion Date	August 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: 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 Criteria: 1. The patient must continue to not meet all of the exclusion criteria of protocol C009
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00849043
Other Study ID Numbers	AERO C009E
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Connie Rey, Ventus Medical, Inc
Study Sponsor	Ventus Medical, Inc.
Collaborators	Not Provided
Investigators	Principal Investigator: Meir Kryger, MD Gaylord Sleep Medicine Research
PRS Account	Ventus Medical, Inc.
Verification Date	January 2011