NCT05497180 Use of Passive Myofunctional Appliances for Snoring and Mild Obstructive Sleep Apnea
| NCT ID | NCT05497180 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Alberta |
| Condition | Sleep Apnea, Obstructive |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-07-23 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2022-07-23 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Frequently Asked Questions
Who can join the NCT05497180 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sleep Apnea, Obstructive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05497180 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05497180 currently recruiting?
Yes, NCT05497180 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Alberta to inquire about joining.
Where is the NCT05497180 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT05497180 clinical trial?
NCT05497180 is sponsored by University of Alberta. The trial plans to enroll 40 participants.