Status:
UNKNOWN
Dual Obstructive Sleep Apnea Therapy
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Université de Montréal
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
19-80 years
Phase:
NA
Brief Summary
Continuous positive airway pressure (CPAP) is considered the gold standard therapy for obstructive sleep apnea (OSA). However, CPAP users sometimes experience pressure-related discomfort. It is though...
Detailed Description
This is a prospective clinical trial assessing the effect of 1-month of dual therapy on patients with varying baseline OSA severity (mild to severe) who have been previously fully titrated to both PAP...
Eligibility Criteria
Inclusion
- Age 19-80 years old who are able to freely provide informed consent;
- Prior participation in the CHOICE study;
- Have been optimally titrated to PAP and MAS therapy;
- Have both PAP and MAS appliances at home and ready for use;
- Body mass index (BMI) of 35 or less;
- ≥ 8 teeth per arch to support treatment with MAS;
- Have an objective of diagnosis of OSA based on the following criteria:
- \- an Apnea-Hypopnea Index (AHI) within the range 10 ≤ AHI ≤ 70 documented with polysomnography in the last 2 years; \*\*\*OR\*\*\*
- \- a Respiratory Disturbance Index (RDI) within the range 20 ≤ RDI ≤ 70 documented with level III portable sleep test; \*\*\*OR\*\*\*
- \- an Oxygen Desaturation Index (ODI) ≥ 10;
- Sleep investigations confirming the object diagnosis of OSA have been performed within the past 4 years
Exclusion
- Use of a full face mask as the PAP interface;
- Extensive periodontal disease with significant tooth mobility;
- Inability to protrude jaw;
- Insufficient vertical opening to accommodate treatment with MAS;
- 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);
- History of a near miss or prior automobile accident due to sleepiness within the past 12 months;
- At nighttime, 30% of the night is at ≤ 90% oxygen saturation levels.
Key Trial Info
Start Date :
March 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03435731
Start Date
March 8 2018
End Date
December 1 2018
Last Update
May 2 2018
Active Locations (2)
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1
University of British Columbia
Vancouver, British Columbia, Canada, V6T 1Z3
2
Université de Montréal
Montreal, Quebec, Canada, H3T 1J4