TerminatedNot Applicable

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

Stopped: Inability to further include additional patients

Canada, France15 participantsStarted 2013-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

CPAP compliance

Timeframe: After 4 weeks of CPAP trial

Trial details

NCT IDNCT01889472

SponsorLaval University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-01-18

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials