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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00849043

Acronym

AERO C009E

Enrollment

Registered

2009-02-23

Start date

2009-02-28

Completion date

2010-10-31

Last updated

2011-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea, Obstructive Sleep Apnea Hypopnea, OSAH

Keywords

obstructive sleep apnea hypopnea, OSA, OSAH

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.

Interventions

None listed

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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	12 months

Secondary

Measure	Time frame
Measurement of the subjects quality of life	12 months

Countries

United States

Outcome results