Using passive appliances to treat snoring and mild sleep apnea
Use of Passive Myofunctional Appliances for Snoring and Mild Obstructive Sleep Apnea
PHASE1 · University of Alberta · NCT05497180
This study is testing if special mouthpieces can help people with mild sleep apnea and snoring breathe better while sleeping, and if they work better than regular mouthpieces.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alberta (other) |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05497180 on ClinicalTrials.gov |
What this trial studies
This study explores the effectiveness of passive myofunctional appliances as a treatment option for patients suffering from mild obstructive sleep apnea and snoring. It aims to determine the appropriate sizing for individual patients and assess whether these appliances can serve as a transitional or direct treatment method. The study utilizes innovative techniques, such as speech-based mandibular positioning, to potentially reduce side effects associated with traditional oral appliances. By comparing passive appliances to standard oral appliances, the research seeks to provide a quicker and more cost-effective solution for patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with mild obstructive sleep apnea or snoring without sleep apnea.
Not a fit: Patients who have previously been diagnosed as non-responders to oral appliance therapy or those undergoing other active therapies for sleep apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a faster and less expensive treatment option for patients with mild obstructive sleep apnea and snoring.
How similar studies have performed: While there is existing literature on myofunctional therapy's effectiveness, the specific use of passive myofunctional appliances for this purpose is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Edmonton, Alberta
- Enjoy Dental — Edmonton, Alberta, Canada (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sleep Apnea, Obstructive, Mandibular Advancement Devices, Myofunctional Therapy