Clinical trial NCT00849043: Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea
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
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea Hypopnea
Obstructive Sleep Apnea
OSAH
Keywords: obstructive sleep apnea hypopnea
OSA
OSAH
Lead sponsor: Ventus Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2009-02-23
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
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.

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: Measurement of the subjects quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Wallingford
country: United States
facility: Gaylord Sleep Medicine Research
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida Health Science Center
state: Florida
city: Atlanta
country: United States
facility: Sleep Disorders Center of Georgia
state: Georgia
city: Elk Grove Village
country: United States
facility: Suburban Lung Associates
state: Illinois
city: Louisville
country: United States
facility: Kentucky Research Group
state: Kentucky
city: Brighton
country: United States
facility: Sleep HealthCenters
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University Harper Univ. Hospital
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Research
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Chesterfield
country: United States
facility: St. Luke's Hospital Sleep Medicine & Research Center
state: Missouri
city: Corvallis
country: United States
facility: The Corvallis Clinic
state: Oregon
city: Dallas
country: United States
facility: Sleep Medicine Associates of Texas
state: Texas
city: San Antonio
country: United States
facility: Sleep Therapy and Research Center
state: Texas
Study officials:
affiliation: Gaylord Sleep Medicine Research
name: Meir Kryger, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.