Use of Passive Myofunctional Appliances for Snoring and Mild Obstructive Sleep Apnea
Primary Purpose
Sleep Apnea, Obstructive
Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
passive myofunctional appliance
standard oral appliance
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Mandibular Advancement Devices, Myofunctional Therapy
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.
Sites / Locations
- Enjoy DentalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Passive Myofunctional Appliance
Oral Appliance Therapy
Arm Description
provision of passive myofunctional appliance
provision of mandibular advancement device
Outcomes
Primary Outcome Measures
Snoring volume
Decibel volumetric recordings with SnoreLab app
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05497180
Brief Title
Use of Passive Myofunctional Appliances for Snoring and Mild Obstructive Sleep Apnea
Official Title
Use of Passive Myofunctional Appliances for Snoring and Mild Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 23, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
Mandibular Advancement Devices, Myofunctional Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Passive Myofunctional Appliance
Arm Type
Experimental
Arm Description
provision of passive myofunctional appliance
Arm Title
Oral Appliance Therapy
Arm Type
Active Comparator
Arm Description
provision of mandibular advancement device
Intervention Type
Device
Intervention Name(s)
passive myofunctional appliance
Intervention Description
passive myofunctional appliance
Intervention Type
Device
Intervention Name(s)
standard oral appliance
Intervention Description
standard oral appliance
Primary Outcome Measure Information:
Title
Snoring volume
Description
Decibel volumetric recordings with SnoreLab app
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Enjoy Dental
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5X 3N5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enoch Ng, DDS
Phone
780-407-5550
Email
enoch@ualberta.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Passive Myofunctional Appliances for Snoring and Mild Obstructive Sleep Apnea
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