Clinical trial NCT05497180: 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
Overall status: RECRUITING
Phase: PHASE1
Conditions: Sleep Apnea, Obstructive
Keywords: Mandibular Advancement Devices
Myofunctional Therapy
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Snoring volume
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Enjoy Dental
state: Alberta
Study officials:
References: