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

Ventus Medical, Inc.13 sites in 1 country65 target enrollmentFebruary 2009

ConditionsObstructive Sleep Apnea Hypopnea Obstructive Sleep Apnea OSAH

Overview

Phase: N/A
Intervention: Not specified
Conditions: Obstructive Sleep Apnea Hypopnea
Sponsor: Ventus Medical, Inc.
Enrollment: 65
Locations: 13
Primary Endpoint: 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
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2009

End Date

October 2010

Last Updated

15 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Ventus Medical, Inc.

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

•The patient must continue to not meet all of the exclusion criteria of protocol C009

Outcomes

Primary Outcomes

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