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
1 other identifier
observational
30
1 country
8
Brief Summary
Prospective observational study of obstructive Sleep Apnea patients treated with Bilevel Positive Airway Pressure: AirCurve 10 VAutoTM
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2016
Typical duration for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2016
CompletedFirst Posted
Study publicly available on registry
October 12, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2019
CompletedFebruary 28, 2020
April 1, 2017
2 years
October 10, 2016
February 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Compliance
hours of usage of the device per night
3 months
Secondary Outcomes (2)
sleepiness
3 months
sleep quality
3 months
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Bilevel positive airway pressure Contraindication
- Severe respiratory disease diagnostic
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ResMedlead
Study Sites (8)
CH de Belfort
Belfort, France
Clinique Aguilera
Biarritz, France
Cabinet de Pneumologie
Blois, France
HCL - Croix-Rousse Hospital
Lyon, 69004, France
APHM
Marseille, France
Centre médical du sommeil
Metz, France
Hopital Saint Antoine
Paris, 75000, France
Polyclinique Saint-Laurent
Rennes, 35706, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alain Palot, MD
CHU Marseille
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2016
First Posted
October 12, 2016
Study Start
November 1, 2016
Primary Completion
November 1, 2018
Study Completion
February 28, 2019
Last Updated
February 28, 2020
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share