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

NCT ID: NCT05497180

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-23
• Study Completion Date: 2027-07-31

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).

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.

Conditions

Sleep Apnea, Obstructive

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Passive Myofunctional Appliance

provision of passive myofunctional appliance

Group Type: EXPERIMENTAL

passive myofunctional appliance

Intervention Type: DEVICE

passive myofunctional appliance

Oral Appliance Therapy

provision of mandibular advancement device

Group Type: ACTIVE_COMPARATOR

standard oral appliance

Intervention Type: DEVICE

standard oral appliance

Interventions

passive myofunctional appliance

passive myofunctional appliance

Intervention Type: DEVICE

standard oral appliance

standard oral appliance

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Enjoy Dental

Edmonton, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Enoch Ng, DDS

Role: primary

enoch@ualberta.ca

780-407-5550

Other Identifiers

00117371

Identifier Type: -

Identifier Source: org_study_id