RecruitingPhase 1

Use of Passive Myofunctional Appliances for Snoring and Mild Obstructive Sleep Apnea

Canada40 participantsStarted 2022-07-23

Plain-language summary

It is unknown whether passive myofunctional appliances can be used for the treatment of obstructive sleep apnea and snoring, nor how to select the appropriate size per individual patient. Exploring the possibility of using passive myofunctional appliances as a treatment option for patients with mild obstructive sleep apnea and/or snoring should be considered, especially as the time to fabricate and deliver custom designed dental sleep appliances can be significant (sometimes over a month). Use of passive myofunctional appliances as a transitional appliance or potentially as direct treatment for obstructive sleep apnea may significantly decrease time to treatment and also provide a less expensive treatment option for patients with obstructive sleep apnea. The purpose of this study is to determine whether passive myofunctional appliances can be used as a treatment option for patients suffering from snoring and mild obstructive sleep apnea (OSA).

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: * Patients diagnosed with mild obstructive sleep apnea or snoring without sleep apnea. * Patients 18 years or older * Patients able to provide consent to treatment and participation in the study Exclusion Criteria: * Patients previously diagnosed as non-responders to oral appliance therapy for their sleep apnea * Patients undergoing other active therapies for their sleep apnea * Patients with a history of airway/sleep breathing surgical interventions * Participants with a history of airway/sleep breathing surgical intervention are not eligible to be a part of this study do to risk of skewing test results * Patients with craniofacial, syndromic, or neuromuscular disorders * Patients with acute medical conditions requiring immediate attention * Participants with an acute medical problem will be immediately referred to an appropriate physician and will not be allowed to enroll in the study until their health conditions are stable.

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

Snoring volume

Timeframe: 3 months

Trial details

NCT IDNCT05497180

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07

View on ClinicalTrials.gov More Sleep Apnea, Obstructive trials