Prospective Cohort Study of Patients Intolerant to High Pressure Under Continuous Positive Airway Pressure Treated With Bilevel Positive Airway Pressure as Second-line Therapy.
Overview
Prospective observational study of obstructive Sleep Apnea patients treated with Bilevel Positive Airway Pressure: AirCurve 10 VAutoTM
Full Title of Study: “Prospective Cohort Study of Patients Intolerant to High Pressure Under Continuous Positive Airway Pressure, Treated With Bilevel Positive Airway Pressure (AirCurve 10 VAutoTM) as Second-line Therapy: PoP IN VAuto”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: November 2018
Detailed Description
To characterize, in routine practice, non compliant patient to continuous positive airway pressure who can get a benefit of a bilevel positive airway pressure therapy as a second line treatment (Aircurve 10 VAutoTM ) To evaluate the clinical management of obstructive sleep apnea patients treated by Aircurve 10 VAutoTM , especially impact on compliance and residual apnea hypopnea Index. To evaluate Aircurve 10 VAutoTM benefit on quality of Life and quality of sleep
Clinical Trial Outcome Measures
Primary Measures
- Compliance
- Time Frame: 3 months
- hours of usage of the device per night
Secondary Measures
- sleepiness
- Time Frame: 3 months
- Epworth sleepiness score evolution
- sleep quality
- Time Frame: 3 months
- Pittsburgh sleep questionnaire index
Participating in This Clinical Trial
Inclusion Criteria
- Adult patient – Obstructive Sleep Apnea Patient previously treated by Continuous positive airway pressure non-compliant to therapy – Patient naive of bilevel Positive Airway Pressure therapy Exclusion Criteria:
- Bilevel positive airway pressure Contraindication – Severe respiratory disease diagnostic
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- ResMed
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Alain Palot, MD, Principal Investigator, CHU Marseille
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