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Clinical Trials/NCT01889472
NCT01889472
Terminated
Not Applicable

Impact of Nasal Mask/Oronasal Mask on Compliance to Treatment With Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea

Laval University3 sites in 2 countries15 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
Laval University
Enrollment
15
Locations
3
Primary Endpoint
CPAP compliance
Status
Terminated
Last Updated
8 years ago

Overview

Brief Summary

CPAP is the most effective treatment of obstructive sleep apnea. Oro-nasal masks may be used in case of mouth leaks but these are associated with higher positive pressure needs and lower compliance to treatment. The present investigation evaluates if CPAP compliance would increase when an oral appliance is used in combination with a nasal mask compared to the use of an oro-nasal mask. Eligible patients are those demonstrating a low compliance when using an oro-nasal mask during CPAP therapy. Patients will be treated with automatic CPAP with one of the above-detailed interfaces for 4 weeks and data will be extracted from the machine report in each condition.

Detailed Description

Participating subjects will be currently treated by CPAP and low compliance will be assessed according to machine report download demonstrating 3h or less of CPAP usage per night.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
January 18, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Frédéric Sériès

Director IUCPQ sleep laboratory

Laval University

Eligibility Criteria

Inclusion Criteria

  • normal nasal breathing
  • dentition allowing for use of an oral appliance
  • absence of mandibular joint pathology
  • Patients requiring the use of a facial mask during CAPP titration due to presence of mouth leaks with a nasal/prong interface
  • Patients using CPAP less than 3 hours/day as prescribed following CPAP titration

Exclusion Criteria

  • Clinical instability
  • smoking cessation
  • current weight loss strategy
  • Marked anatomic abnormalities of upper airway (i.e. macroglossia, tonsils hypertrophy)
  • severe cardio-metabolic co-morbidity

Outcomes

Primary Outcomes

CPAP compliance

Time Frame: After 4 weeks of CPAP trial

CPAP compliance will be assessed according to machine report download for the 4 weeks of treatment in each study condition.

Secondary Outcomes

  • diurnal somnolence(After 4 weeks of CPAP trial)

Study Sites (3)

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