Adherence and Preference of Continuous Positive Airway Pressure Versus Mandibular Advancement Splints in Obstructive Sleep Apnea Patients: A Randomized Trial

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 for patients with mild to severe OSA. The secondary aim is to assess if patient preference does correlate to the final treatment adherence. An exploratory aim is to assess if the strategy of patients having both treatments available to use interchangeably could further improve treatment adherence, sleepiness, quality of life and fatigue. Having a better insight into patient adherence will improve the cost-effectiveness of treatment and will improve the health and quality of life for many Canadians who suffer from sleep apnea.

The proposed trial is a randomized open-label, two-treatment, two-period cross-over trial followed by an observational trial. Sixty OSA patients (10≤AHI≤50) will receive both PAP and MAS. As a recent innovation, we have adherence monitors for MAS that can give a new and comprehensive comparative analysis of the effectiveness between MAS and PAP. In the randomized trial phase the two treatments will be used separately for 1 month each (after treatment adaptation/titration of 1-2 months for each device). Treatment efficacy and daily treatment use data will be assessed together with changes in symptoms (quality of life, sleepiness and fatigue). Patient initial preference will be determined by using a patient decision aid. This will be followed by the observational trial phase, where all patients will have access to both interventions at home for 6 months and be allowed to choose on a daily basis the intervention to use. The intervention duration of 6 months is to allow for a sustained response in long-term adherence and to observe changes in quality of life.

Inclusion criteria

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 criteria

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.