Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea (AERO C009E)
This study has been completed.
Sponsor:
Ventus Medical, Inc.
Information provided by:
Ventus Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00849043
First received: February 19, 2009
Last updated: January 25, 2011
Last verified: January 2011
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Purpose
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.
| Study Type: | Observational |
| 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 |
Resource links provided by NLM:
Further study details as provided by Ventus Medical, Inc.:
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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Measurement of the subjects quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 65 |
| Study Start Date: | February 2009 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Provent
Provent Professional Sleep Apnea Therapy device
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849043
Locations
| United States, Connecticut | |
| Gaylord Sleep Medicine Research | |
| Wallingford, Connecticut, United States, 06492 | |
| United States, Florida | |
| University of Florida Health Science Center | |
| Gainesville, Florida, United States, 32610-0225 | |
| United States, Georgia | |
| Sleep Disorders Center of Georgia | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Illinois | |
| Suburban Lung Associates | |
| Elk Grove Village, Illinois, United States, 60007 | |
| United States, Kentucky | |
| Kentucky Research Group | |
| Louisville, Kentucky, United States, 40217 | |
| United States, Massachusetts | |
| Sleep HealthCenters | |
| Brighton, Massachusetts, United States, 02135 | |
| United States, Michigan | |
| Wayne State University Harper Univ. Hospital | |
| Detroit, Michigan, United States, 48201 | |
| Borgess Research | |
| Kalamazoo, Michigan, United States, 49024 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| St. Luke's Hospital Sleep Medicine & Research Center | |
| Chesterfield, Missouri, United States, 63001 | |
| United States, Oregon | |
| The Corvallis Clinic | |
| Corvallis, Oregon, United States, 97330 | |
| United States, Texas | |
| Sleep Medicine Associates of Texas | |
| Dallas, Texas, United States, 75231 | |
| Sleep Therapy and Research Center | |
| San Antonio, Texas, United States, 07829 | |
Sponsors and Collaborators
Ventus Medical, Inc.
Investigators
| Principal Investigator: | Meir Kryger, MD | Gaylord Sleep Medicine Research |
More Information
No publications provided by Ventus Medical, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Connie Rey, Ventus Medical, Inc |
| ClinicalTrials.gov Identifier: | NCT00849043 History of Changes |
| Other Study ID Numbers: | AERO C009E |
| Study First Received: | February 19, 2009 |
| Last Updated: | January 25, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ventus Medical, Inc.:
|
obstructive sleep apnea hypopnea OSA OSAH |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013