Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea (AERO C009E)
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ClinicalTrials.gov Identifier: NCT00849043 |
Recruitment Status
:
Completed
First Posted
: February 23, 2009
Last Update Posted
: January 26, 2011
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Sponsor:
Ventus Medical, Inc.
Information provided by:
Ventus Medical, Inc.
Tracking Information | ||||
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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 |
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 |
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 |
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 |
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Intervention | Not Provided | |||
Study Groups/Cohorts | Provent
Provent Professional Sleep Apnea Therapy device |
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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. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Estimated Enrollment |
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:
Exclusion Criteria: 1. The patient must continue to not meet all of the exclusion criteria of protocol C009 |
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Sex/Gender |
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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 |
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PRS Account | Ventus Medical, Inc. | |||
Verification Date | January 2011 |