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

Ventus Medical, Inc.65 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Obstructive Sleep Apnea Hypopnea Obstructive Sleep Apnea OSAH

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Gaylord Sleep Medicine Research

Wallingford, Connecticut, United States

University of Florida Health Science Center

Gainesville, Florida, United States

Sleep Disorders Center of Georgia

Atlanta, Georgia, United States

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

Secondary Outcomes

Measurement of the subjects quality of life

Time frame: 12 months

Data from ClinicalTrials.gov

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