Use of Passive Myofunctional Appliances for Snoring and Mild Obstructive Sleep Apnea
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Alberta
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Edmonton, Alberta, Canada, T5X 3N5
- Recruiting
- Enjoy Dental
-
Contact:
- Enoch Ng, DDS
- Phone Number: 780-407-5550
- Email: enoch@ualberta.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Passive Myofunctional Appliance
provision of passive myofunctional appliance
|
passive myofunctional appliance
|
|
Active Comparator: Oral Appliance Therapy
provision of mandibular advancement device
|
standard oral appliance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Snoring volume
Time Frame: 3 months
|
Decibel volumetric recordings with SnoreLab app
|
3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00117371
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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