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

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Adherence, CPAP, Oral Appliance, Mandibular Advancement Splints, Preference Read More

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• You are pregnant (if a female participant becomes pregnant during the trial, she will be withdrawn from the study);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.