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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