Abstract
Background: Long-term MRD efficacy in OSA pts noncompliant with continuous positive airway pressure (CPAP) is not well documented.
Aim: ORCADES is a French prospective multicenter cohort study evaluating the clinical benefits of a custom-made MRD over 5 years in >300 OSA pts who refused or did not tolerate CPAP. Interim results at 3-6 months follow-up (FU) are presented.
Methods: Eligible OSA pts fitted with a CAD/CAM MRD (Narval CC™) had gradual mandibular advancement (MA) until the best benefit-risk ratio. Sleep data, symptoms, quality of life, side effects and compliance were evaluated over 5-years' FU. Treatment success: ≥50% decrease in apnoea-hypopnoea index (AHI) from baseline.
Results: Data on 312 pts treated with the CAD/CAM MRD were available (76% male, age 53±12 years, body mass index 27±4 kg/m2, 42% with AHI >30/h). Mean final MA was 7±2 mm (80% maximum MA). Mean AHI decreased from 29±15 to 10±12. Treatment success rate was 79% (95% CI 74-83%), irrespective of OSA severity. AHI was <10/h in 66% of pts. Of pts with AHI>30, 60% and 40%, respectively, were effectively treated or cured. Mean Epworth Sleepness Scale reduced from 11±5 to 8±4. Loud snoring disappeared in 89% of pts affected. Symptoms and quality of life improved significantly. Mean MRD usage was 6.7 hours/night on a mean of 6.8 days/week. Overall, 25 pts (8%) stopped MRD due to side effects. Independent predictors of success were less abdominal obesity and deeper overbite.
Conclusions: These interim results confirm the clinical benefits of custom-made CAD/CAM MRD in mild to severe OSA. This device can be used when CPAP fails, with few side effects and excellent compliance.
- © 2014 ERS