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

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

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.

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