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

NCT ID: NCT02930460

Last Updated: 2020-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-02-28

Brief Summary

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

Detailed Description

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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

Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ResMed

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alain Palot, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Marseille

Locations

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CH de Belfort

Belfort, , France

Site Status

Clinique Aguilera

Biarritz, , France

Site Status

Cabinet de Pneumologie

Blois, , France

Site Status

HCL - Croix-Rousse Hospital

Lyon, , France

Site Status

APHM

Marseille, , France

Site Status

Centre médical du sommeil

Metz, , France

Site Status

Hopital Saint Antoine

Paris, , France

Site Status

Polyclinique Saint-Laurent

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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PoP IN VAuto

Identifier Type: -

Identifier Source: org_study_id

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