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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02930460

Acronym

PoP IN VAuto

Enrollment

Registered

2016-10-12

Start date

2016-11-30

Completion date

2019-02-28

Last updated

2020-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Brief summary

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

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Compliance	3 months	hours of usage of the device per night

Secondary

Measure	Time frame	Description
sleepiness	3 months	Epworth sleepiness score evolution
sleep quality	3 months	Pittsburgh sleep questionnaire index

Countries

France

Outcome results