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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00849043
Recruitment Status : Completed
First Posted : February 23, 2009
Last Update Posted : January 26, 2011
Information provided by:
Ventus Medical, Inc.

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.

Condition or disease
Obstructive Sleep Apnea Hypopnea Obstructive Sleep Apnea OSAH

Study Type : Observational
Estimated Enrollment : 65 participants
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
Study Start Date : February 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Provent Professional Sleep Apnea Therapy device

Primary Outcome Measures :
  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 [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Measurement of the subjects quality of life [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00849043

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.
Principal Investigator: Meir Kryger, MD Gaylord Sleep Medicine Research

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Connie Rey, Ventus Medical, Inc Identifier: NCT00849043     History of Changes
Other Study ID Numbers: AERO C009E
First Posted: February 23, 2009    Key Record Dates
Last Update Posted: January 26, 2011
Last Verified: January 2011

Keywords provided by Ventus Medical, Inc.:
obstructive sleep apnea hypopnea

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases