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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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