Impact of Interface With/Without Oral Appliance of Sleep Apnea Treatment

Not Applicable

Terminated

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy

• Registration Number: NCT01889472
• Lead Sponsor: Laval University

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-19
• Study First Submitted QC: 2013-06-26
• Study First Posted: 2013-06-28
• Primary Completion: 2017-01-18
• Study Completion: 2017-01-18
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nasal mask and oral appliance	Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy	Nasal mask and oral appliance during 1 month of auto CPAP
oro-nasal mask	Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy	Oro-nasal mask during 1 month of auto CPAP

Primary Outcome Measures

Name	Time	Method
CPAP compliance	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 Outcome Measures

Name	Time	Method
diurnal somnolence	After 4 weeks of CPAP trial	Epworth Sleepiness Score

Trial Locations

Locations (3)

AGIRADOM; 🇫🇷 Grenoble, France

CHUM; 🇨🇦 Montreal, Quebec, Canada

IUCPQ; 🇨🇦 Quebec, Canada