Status:
COMPLETED
Adherence and Preference of Continuous Positive Airway Pressure Versus Mandibular Advancement Splints in Obstructive Sleep Apnea Patients: A Randomized Trial
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Université de Montréal
Laval University
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
19-75 years
Phase:
NA
Brief Summary
Obstructive sleep apnea (OSA) is a major health problem affecting over 1,000,000 Canadians. It is the cause of significant healthcare costs with increased morbidity and mortality. The two most common ...
Detailed Description
The primary aim of this study is to assess objective adherence to treatment, for PAP and MAS, and to evaluate if there will be similar effectiveness (efficacy+adherence) between PAP and MAS treatment ...
Eligibility Criteria
Inclusion
- You may be able to participate in this study if:
- You are naïve to treatment (never used CPAP or oral appliance, nor had surgery for sleep apnea);
- You are between 19-75 years old;
- You have a Body Mass Index (BMI) ≤ 35;
- You have enough teeth (at least 8 per arch) for MAS;
- You have:
- an Apnea-Hypopnea Index (AHI) within the range 10 ≤ AHI ≤ 50 documented with polysomnography in the last 2 years; \*\*\*OR\*\*\*
- a Respiratory Disturbance Index (RDI) within the range 20 ≤ RDI ≤ 50 documented with level III portable sleep test; \*\*\*OR\*\*\*
- an Oxygen Desaturation Index (ODI) ≥ 10; and
- You have had a sleep test within the past 2 years.
Exclusion
- You may not be able to participate in this study if:
- You have extensive periodontal disease with significant tooth mobility (disease around your teeth);
- You are unable to protrude the jaw (unable to extend your jaw);
- You have a lack of a sufficient vertical opening to accommodate an appliance;
- You have uncontrolled congestive heart failure (defined as a prior clinical diagnosis, an ejection cutoff of 40% or a clinical sign in the opinion of a primary care physician or cardiologist) that makes it unsafe for you to participate in the trial in the opinion of the investigators;
- You have coronary artery disease unless stable for at least 6 months and considered by the investigators to have a stable disease;
- You have a history of angina (chest pain when your heart does not get enough blood), myocardial infarction (heart attack) or stroke;
- You have a history of major depressive disorder (such as bipolar disorder) along with current moderate or severe disease;
- You have cancer unless in remission (decreasing signs of your cancer being present) for more than 1 year;
- You have known renal (kidney) failure with need for dialysis;
- You are pregnant (if a female participant becomes pregnant during the trial, she will be withdrawn from the study);
- You have had a near miss or prior automobile accident due to sleepiness within the past 12 months; and/or
- At nighttime, 30% of the night is at ≤ 90% oxygen saturation levels.
Key Trial Info
Start Date :
November 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT02242617
Start Date
November 1 2015
End Date
June 1 2020
Last Update
November 30 2022
Active Locations (3)
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1
University of British Columbia
Vancouver, British Columbia, Canada, V6T 1Z3
2
University of Montreal / Université de Montréal
Montreal, Quebec, Canada, H3T 1J4
3
Laval University / Université Laval
Québec, Canada, G1V 4G5