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Behavioural Intervention

Myofunctional Appliances for Sleep Apnea

Phase 1
Recruiting
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients 18 years or older
Be older than 18 years old
Must not have
Patients undergoing other active therapies for their sleep apnea
Patients previously diagnosed as non-responders to oral appliance therapy for their sleep apnea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether passive myofunctional appliances, which are less expensive and quicker to make than other options, can be an effective treatment for patients with mild obstructive sleep apnea and/or snoring.

Who is the study for?
This trial is for adults over 18 with mild obstructive sleep apnea or snoring, who can legally consent to treatment. It's not for those who've had airway surgery, are on other sleep apnea therapies, didn't respond to oral appliances before, or have craniofacial/syndromic/neuromuscular disorders.
What is being tested?
The study tests if passive myofunctional appliances can treat mild obstructive sleep apnea and snoring. It compares these appliances to standard ones and looks at how to choose the right size for patients as a quicker, cheaper treatment option.
What are the potential side effects?
Potential side effects aren't specified but may include discomfort from wearing the appliance, jaw pain, changes in bite alignment, excessive salivation or dry mouth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently receiving treatment for my sleep apnea.
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My sleep apnea did not improve with a mouth device.
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I have never had surgery for sleep or breathing issues.
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I have had surgery for sleep or breathing issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Snoring volume

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Passive Myofunctional ApplianceExperimental Treatment1 Intervention
provision of passive myofunctional appliance
Group II: Oral Appliance TherapyActive Control1 Intervention
provision of mandibular advancement device

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of AlbertaLead Sponsor
940 Previous Clinical Trials
433,991 Total Patients Enrolled

Media Library

Obstructive Sleep Apnea Clinical Trial 2023: Passive Myofunctional Appliance Highlights & Side Effects. Trial Name: NCT05497180 — Phase 1
~8 spots leftby Jul 2025
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