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

Obstructive Sleep Apnea Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00849043
• Other study ID #: AERO C009E
• Status: Completed
• Phase: Phase 3
• First received: February 19, 2009
• Last updated: January 25, 2011
• Start date: February 2009
• Est. completion date: October 2010

Study information

• Verified date: January 2011
• Source: Ventus Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Obstructive Sleep Apnea Hypopnea
• OSAH
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United States	Sleep Disorders Center of Georgia	Atlanta	Georgia
United States	Sleep HealthCenters	Brighton	Massachusetts
United States	St. Luke's Hospital Sleep Medicine & Research Center	Chesterfield	Missouri
United States	The Corvallis Clinic	Corvallis	Oregon
United States	Sleep Medicine Associates of Texas	Dallas	Texas
United States	Wayne State University Harper Univ. Hospital	Detroit	Michigan
United States	Suburban Lung Associates	Elk Grove Village	Illinois
United States	University of Florida Health Science Center	Gainesville	Florida
United States	Borgess Research	Kalamazoo	Michigan
United States	Kentucky Research Group	Louisville	Kentucky
United States	Mayo Clinic	Rochester	Minnesota
United States	Sleep Therapy and Research Center	San Antonio	Texas
United States	Gaylord Sleep Medicine Research	Wallingford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Ventus Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12 months	Yes
Secondary	Measurement of the subjects quality of life		12 months	No