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

NCT05497180 | Recruiting Phase 1 DMC

• 1 other identifier: 00117371
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Mandibular Advancement Devices; Myofunctional Therapy

Outcome Measures

Primary Outcomes (1)

• Snoring volume

  Decibel volumetric recordings with SnoreLab app

  3 months

Study Arms (2)

Passive Myofunctional Appliance

EXPERIMENTAL

provision of passive myofunctional appliance

Device: passive myofunctional appliance

Oral Appliance Therapy

ACTIVE COMPARATOR

provision of mandibular advancement device

Device: standard oral appliance

Interventions

passive myofunctional appliance DEVICE

passive myofunctional appliance

Passive Myofunctional Appliance

standard oral appliance DEVICE

standard oral appliance

Oral Appliance Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Enjoy Dental

Edmonton, Alberta, T5X 3N5, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 11, 2022
• Study Start: July 23, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)