Status:
UNKNOWN
Determinants of Tooth Movement in Oral Appliance Treatment of OSA.
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Université de Montréal
Laval University
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief Summary
Obstructive sleep apnea (OSA) is a sleep related breathing disorder, affecting approximately 10% of adults. Mandibular advancement oral appliances (OAM) are an effective treatment for OSA, however, lo...
Detailed Description
Mandibular advancement oral appliances (OAM) are an effective treatment for obstructive sleep apnea (OSA). However, prolonged OAM treatment leads to significant changes in occlusion for the majority o...
Eligibility Criteria
Inclusion
- Treatment naive (have never used an oral appliance as treatment for OSA);
- Age 25 - 65 years old, who are able to freely provide informed consent;
- Body Mass Index (BMI) ≤ 35;
- 8 or more teeth per arch to support treatment with OAM;
- Apnea-Hypopnea Index (AHI) within the range 5≤AHI≤50 documented with polysomnography in the last 2 years \*\*\*OR\*\*\*
- Respiratory Disturbance Index (RDI) within the range 20 ≤ RDI ≤ 50 documented with level III portable sleep test \*\*\*OR\*\*\*
- Oxygen Desaturation Index (ODI) ≥ 10
Exclusion
- Extensive periodontal disease with significant tooth mobility;
- Inability to protrude jaw;
- Insufficient vertical opening to accommodate treatment with OAM;
- Pregnancy (if a participant becomes pregnant during the trial, the participant will be withdrawn from the study).
- Uncontrolled congestive heart failure (defined as a prior clinical diagnosis, an ejection cut-off of 40% or clinical sign in the opinion of a primary care physician or cardiologist) that makes it unsafe in the opinion of the investigators for the subject to participate in the trial;
- Coronary artery disease unless stable for at least 6 months and considered by the investigators to have a stable disease;
- Any history of angina, myocardial infarction or stroke;
- Any history of major depressive disorder along with current moderate-severe disease;
- Active cancer management (unless in remission for more than 1 year);
- Known renal failure (with need for dialysis)
Key Trial Info
Start Date :
August 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT03341130
Start Date
August 22 2018
End Date
December 1 2024
Last Update
September 28 2023
Active Locations (1)
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1
University of British Columbia
Vancouver, British Columbia, Canada, V6T 1Z3