Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-Hypopnea - Full Text View

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

This study is enrolling participants by invitation only.

First Received: February 19, 2009 Last Updated: May 28, 2009 History of Changes

Sponsored by:	Ventus Medical, Inc.
Information provided by:	Ventus Medical, Inc.
ClinicalTrials.gov Identifier:	NCT00849043

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.

Condition	Phase
Obstructive Sleep Apnea Hypopnea OSA OSAH	Phase III

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:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	65
Study Start Date:	February 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	March 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, Arizona
Pulmonary Associates
Phoenix, Arizona, United States, 85006
Pulmonary Associates
Glendale, Arizona, United States, 85306
United States, California
Stanford Sleep Medicine Center
Redwood City, California, United States, 94063
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
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

Responsible Party:	Ventus Medical, Inc ( Connie Rey )
Study ID Numbers:	AERO C009E
Study First Received:	February 19, 2009
Last Updated:	May 28, 2009
ClinicalTrials.gov Identifier:	NCT00849043 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Ventus Medical, Inc.:

obstructive sleep apnea hypopnea
OSA
OSAH

Study placed in the following topic categories:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders

Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Nervous System Diseases
Respiration Disorders

Sleep Apnea, Obstructive
Sleep Disorders
Dyssomnias
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on August 30, 2009