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

Obstructive Sleep Apnea Clinical Trial

— PoP IN VAuto  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02930460
• Other study ID #: PoP IN VAuto
• Status: Terminated
• Start date: November 2016
• Est. completion date: February 28, 2019

Study information

• Verified date: April 2017
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: February 28, 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
France	CH de Belfort	Belfort
France	Clinique Aguilera	Biarritz
France	Cabinet de Pneumologie	Blois
France	HCL - Croix-Rousse Hospital	Lyon
France	APHM	Marseille
France	Centre médical du sommeil	Metz
France	Hopital Saint Antoine	Paris
France	Polyclinique Saint-Laurent	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance	hours of usage of the device per night	3 months
Secondary	sleepiness	Epworth sleepiness score evolution	3 months
Secondary	sleep quality	Pittsburgh sleep questionnaire index	3 months