Recruiting
Phase 1

Passive Myofunctional Appliances

Sponsor:

University of Alberta

Code:

NCT05497180

Conditions

Sleep Apnea, Obstructive

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

passive myofunctional appliance

standard oral appliance

Study Details

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).

Conditions

Sleep Apnea, Obstructive

Study ID

NCT05497180

Start date

Jul 23, 2022

Status verified date

Aug, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Passive Myofunctional Appliance

provision of passive myofunctional appliance

active comparator: Oral Appliance Therapy

provision of mandibular advancement device

Interventions

passive myofunctional appliance

passive myofunctional appliance

standard oral appliance

standard oral appliance

Primary outcome measure

  • Snoring volume [ Time Frame: 3 months ]

Central Contacts and Locations

Locations

Enjoy Dental

Recruiting

Edmonton, Alberta, Canada, T5X 3N5

Contacts

Enoch Ng, DDS

780-407-5550enoch@ualberta.ca

More Information

Sponsor

University of Alberta

Last update posted

Aug 21, 2025

Last verified

Aug, 2025

Keywords

  • Mandibular Advancement Devices
  • Myofunctional Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-06. This information was provided to ClinicalTrials.gov by University of Alberta on 2025-08-21.