Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05497180 |
| Other study ID # |
00117371 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
July 23, 2022 |
| Est. completion date |
July 2025 |
Study information
| Verified date |
August 2023 |
| Source |
University of Alberta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
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.
