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Sleep Apnea, ObstructivePhase 1NCT05497180

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

A Phase 1 study testing passive myofunctional appliance and standard oral appliance in people with Sleep Apnea, Obstructive, run by University of Alberta at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Sleep Apnea, Obstructive
What is being tested?
passive myofunctional appliance and standard oral appliance
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteCanada
Study dates
23 Jul 2022to Jul 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting
  • Enjoy Dental

    Edmonton, Alberta, T5X 3N5

    Enoch Ng, DDS, 780-407-5550, enoch@ualberta.ca

    Recruiting

Other trials in Canada

About this study

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).

Read the detailed description

Obstructive sleep apnea is a medical condition where a person has great difficulty with breathing, or stops breathing all together, while asleep. This is a medical condition for which one of the current standard treatments is the use of a custom made dental appliance to help hold the person's airway open while asleep so that the person does not suffocate while sleeping. Current methodology within dentistry is to position the mandible somewhere approximately 70% of the person's maximum ability to position their mandible forward as the starting point (George Gauge technique), and then slowly move the bottom jaw forward as necessary. Recent literature (including that published by our team) has shown that different mandibular positioning techniques may require less protrusion, less titrations, and potentially decreased side effects compared with the traditional protrusive techniques. One of the most promising techniques involves the use of speech to determine mandibular position. The sibilant phenome technique would not require that a patient place their jaw outside of their normal functional range, and could potentially decrease the face pain/jaw joint problems commonly associated with the use of oral sleep appliances for the treatment of obstructive sleep apnea.

Myofunctional therapy has been shown to be effective at reducing sleep apnea disease indices for patients with obstructive sleep apnea. It can be thought of as targeted physiotherapy for the face, neck, and mouth muscles (including the lips, cheeks, and tongue). Due to its effectiveness and ability to reduce sleep apnea disease indices by up to 50%, it is considered an effective adjunctive treatment for obstructive sleep apnea. Recently, appliances made to aid in tongue, cheek, lip, and jaw positioning for myofunctional therapy have come onto the market. These are known as passive myofunctional appliances, and are prefabricated with varying sizes available.

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 use of the sibilant phoneme technique may be used for determining the appropriate sizing for which passive myofunctional appliances may be appropriate for individual patients, or if no appropriate sizes are available for use.

Being tested
passive myofunctional appliance, standard oral appliance
Keywords
Mandibular Advancement Devices, Myofunctional Therapy
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • passive myofunctional applianceDevice

    passive myofunctional appliance

  • standard oral applianceDevice

    standard oral appliance

Study groups in NCT05497180
Study groupRoleWhat they receive
Passive Myofunctional ApplianceExperimentalprovision of passive myofunctional appliance
Receives: Device: passive myofunctional appliance
Oral Appliance TherapyActive comparatorprovision of mandibular advancement device
Receives: Device: standard oral appliance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Snoring volume

    Decibel volumetric recordings with SnoreLab app

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2022
  2. Study start23 Jul 2022
  3. Primary completionJul 2030 (estimated)
  4. Study completionJul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05497180
Sponsor's protocol ID
00117371
Status last verified
Sep 2026
First submitted
8 Aug 2022
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing passive myofunctional appliance and standard oral appliance in people with Sleep Apnea, Obstructive, run by University of Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Snoring volume (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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