Prospective Cohort Study of Patients Intolerant to High Pressure Under Continuous Positive Airway Pressure Treated With Bilevel Positive Airway Pressure as Second-line Therapy. (PoP IN VAuto)

February 27, 2020 updated by: ResMed

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

Prospective observational study of obstructive Sleep Apnea patients treated with Bilevel Positive Airway Pressure: AirCurve 10 VAutoTM

Study Overview

Status

Terminated

Conditions

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

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Belfort, France
        • CH de Belfort
      • Biarritz, France
        • Clinique Aguiléra
      • Blois, France
        • Cabinet de Pneumologie
      • Lyon, France, 69004
        • HCL - Croix-Rousse Hospital
      • Marseille, France
        • APHM
      • Metz, France
        • Centre médical du sommeil
      • Paris, France, 75000
        • Hôpital Saint Antoine
      • Rennes, France, 35706
        • Polyclinique Saint-Laurent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Obstructive sleep apnea patient, non compliant or intolerant to Continous positive Airway Pressure therapy, treated by Bilevel Positive Airway Pressure (Aircurve 10 VAutoTM ) as second line therapy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance
Time Frame: 3 months
hours of usage of the device per night
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleepiness
Time Frame: 3 months
Epworth sleepiness score evolution
3 months
sleep quality
Time Frame: 3 months
Pittsburgh sleep questionnaire index
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ResMed

Investigators

  • Principal Investigator: Alain Palot, MD, CHU Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

February 28, 2019

Study Registration Dates

First Submitted

October 10, 2016

First Submitted That Met QC Criteria

October 11, 2016

First Posted (Estimate)

October 12, 2016

Study Record Updates

Last Update Posted (Actual)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PoP IN VAuto

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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