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OpenTrials
Completed

NCT Number: NCT00849043

Extension Study of Original Protocol AERO C009 for 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.

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Key information

Conditions

Obstructive Sleep Apnea Hypopnea Apnea Dyssomnias Nervous System Diseases OSAH Obstructive Sleep Apnea Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gaylord Sleep Medicine Research, Wallingford, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Measurement of the subjects quality of life

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Ventus Medical, Inc.

Industry

Registry information

Official study 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

Acronym: AERO C009E

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 23, 2009
Registry last updated
Jan 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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