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

This study has been completed.
Sponsor:
Information provided by:
Ventus Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00849043
First received: February 19, 2009
Last updated: January 25, 2011
Last verified: January 2011
History of Changes

February 19, 2009
January 25, 2011
February 2009
August 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00849043 on ClinicalTrials.gov Archive Site
Measurement of the subjects quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Measurement of the subjects quality of life [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea
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
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.
Not Provided
Observational
Not Provided
Not Provided
Not Provided
Probability Sample
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.
  • Obstructive Sleep Apnea Hypopnea
  • Obstructive Sleep Apnea
  • OSAH
Not Provided
Provent
Provent Professional Sleep Apnea Therapy device
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.
 
Completed
65
October 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00849043
AERO C009E
No
Not Provided
Not Provided
Connie Rey, Ventus Medical, Inc
Ventus Medical, Inc.
Not Provided
Principal Investigator: Meir Kryger, MD Gaylord Sleep Medicine Research
Ventus Medical, Inc.
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP