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Recruiting Phase 1 NCT05497180

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

Trial Parameters

Condition Sleep Apnea, Obstructive
Sponsor University of Alberta
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 40
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-07-23
Completion 2026-07
Interventions
passive myofunctional appliancestandard oral appliance

Brief 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).

Eligibility Criteria

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.

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