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

Primary Purpose

Obstructive Sleep Apnea Hypopnea, Obstructive Sleep Apnea, OSAH

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
Ventus Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Obstructive Sleep Apnea Hypopnea focused on measuring obstructive sleep apnea hypopnea, OSA, OSAH

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gaylord Sleep Medicine Research
  • University of Florida Health Science Center
  • Sleep Disorders Center of Georgia
  • Suburban Lung Associates
  • Kentucky Research Group
  • Sleep HealthCenters
  • Wayne State University Harper Univ. Hospital
  • Borgess Research
  • Mayo Clinic
  • St. Luke's Hospital Sleep Medicine & Research Center
  • The Corvallis Clinic
  • Sleep Medicine Associates of Texas
  • Sleep Therapy and Research Center

Arms of the Study

Arm 1

Arm Type

Arm Label

Provent

Arm Description

Provent Professional Sleep Apnea Therapy device

Outcomes

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

Secondary Outcome Measures

Measurement of the subjects quality of life

Full Information

First Posted
February 19, 2009
Last Updated
January 25, 2011
Sponsor
Ventus Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00849043
Brief Title
Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea
Acronym
AERO C009E
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 Type
Observational

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ventus Medical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Hypopnea, Obstructive Sleep Apnea, OSAH
Keywords
obstructive sleep apnea hypopnea, OSA, OSAH

7. Study Design

Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Provent
Arm Description
Provent Professional Sleep Apnea Therapy device
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Measurement of the subjects quality of life
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Study Population Description
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.
Sampling Method
Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meir Kryger, MD
Organizational Affiliation
Gaylord Sleep Medicine Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaylord Sleep Medicine Research
City
Wallingford
State/Province
Connecticut
ZIP/Postal Code
06492
Country
United States
Facility Name
University of Florida Health Science Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0225
Country
United States
Facility Name
Sleep Disorders Center of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Suburban Lung Associates
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
Facility Name
Kentucky Research Group
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Sleep HealthCenters
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Wayne State University Harper Univ. Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Borgess Research
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49024
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
St. Luke's Hospital Sleep Medicine & Research Center
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63001
Country
United States
Facility Name
The Corvallis Clinic
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Sleep Medicine Associates of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Sleep Therapy and Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
07829
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22003339
Citation
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.
Results Reference
derived

Learn more about this trial

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

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