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

January 25, 2011 updated by: Ventus Medical, Inc.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Wallingford, Connecticut, United States, 06492
        • Gaylord Sleep Medicine Research
    • Florida
      • Gainesville, Florida, United States, 32610-0225
        • University of Florida Health Science Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Sleep Disorders Center of Georgia
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Suburban Lung Associates
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Kentucky Research Group
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • Sleep HealthCenters
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University Harper Univ. Hospital
      • Kalamazoo, Michigan, United States, 49024
        • Borgess Research
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Chesterfield, Missouri, United States, 63001
        • St. Luke's Hospital Sleep Medicine & Research Center
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • The Corvallis Clinic
    • Texas
      • Dallas, Texas, United States, 75231
        • Sleep Medicine Associates of Texas
      • San Antonio, Texas, United States, 07829
        • Sleep Therapy and Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Provent
Provent Professional Sleep Apnea Therapy device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurement of the subjects quality of life
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ventus Medical, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

February 19, 2009

First Submitted That Met QC Criteria

February 20, 2009

First Posted (Estimate)

February 23, 2009

Study Record Updates

Last Update Posted (Estimate)

January 26, 2011

Last Update Submitted That Met QC Criteria

January 25, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AERO C009E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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