Journal Article

Health Outcomes of Continuous Positive Airway Pressure versus Oral Appliance Treatment for Obstructive Sleep Apnea: A Randomized Controlled Trial

MIHAILIDOU, Anastasia S, MARKS, Guy B, YEE, Brendon J, DARENDELILER, M. Ali, SRINIVASAN, Vasantha K, GRUNSTEIN, Ronald R, PHILLIPS, Craig L, CISTULLI, Peter A

2013

Overview

Continuous positive airway pressure (CPAP) and mandibular advancement device (MAD) therapy are commonly used to treat obstructive sleep apnea (OSA). Differences in efficacy and compliance of these treatments are likely to influence improvements in health outcomes. To compare health effects after 1 month of optimal CPAP and MAD therapy in OSA. In this randomized crossover trial, we compared the effects of 1 month each of CPAP and MAD treatment on cardiovascular and neurobehavioral outcomes. Cardiovascular (24-h blood pressure, arterial stiffness), neurobehavioral (subjective sleepiness, driving simulator performance), and quality of life (Functional Outcomes of Sleep Questionnaire, Short Form-36) were compared between treatments. Our primary outcome was 24-hour mean arterial pressure. A total of 126 patients with moderate-severe OSA (apnea hypopnea index [AHI], 25.6 [SD 12.3]) were randomly assigned to a treatment order and 108 completed the trial with both devices. CPAP was more efficacious than MAD in reducing AHI (CPAP AHI, 4.5 ± 6.6/h; MAD AHI, 11.1 ± 12.1/h; P < 0.01) but reported compliance was higher on MAD (MAD, 6.50 ± 1.3 h per night vs. CPAP, 5.20 ± 2 h per night; P < 0.00001). The 24-hour mean arterial pressure was not inferior on treatment with MAD compared with CPAP (CPAP-MAD difference, 0.2 mm Hg [95% confidence interval, -0.7 to 1.1]); however, overall, neither treatment improved blood pressure. In contrast, sleepiness, driving simulator performance, and disease-specific quality of life improved on both treatments by similar amounts, although MAD was superior to CPAP for improving four general quality-of-life domains. Important health outcomes were similar after 1 month of optimal MAD and CPAP treatment in patients with moderate-severe OSA. The results may be explained by greater efficacy of CPAP being offset by inferior compliance relative to MAD, resulting in similar effectiveness. Clinical trial registered with https://www.anzctr.org.au (ACTRN 12607000289415).

• Publisher: American Thoracic Society,Oxford University Press
• Subject: Adult / Aged / Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy / Automobile Driving / Biological and medical sciences / Blood pressure / Blood Pressure Monitoring, Ambulatory - instrumentation / Clinical trials / Compliance / Computer Simulation / Continuous positive airway pressure / Continuous Positive Airway Pressure - instrumentation / Continuous Positive Airway Pressure - methods / Continuous Positive Airway Pressure - statistics & numerical data / Cross-Over Studies / Fatigue - etiology / Fatigue - physiopathology / Female / Humans / Hypertension - etiology / Hypertension - physiopathology / Intensive care medicine / Male / Mandibular Advancement - instrumentation / Mandibular Advancement - methods / Mandibular Advancement - statistics & numerical data / Medical sciences / Middle Aged / New South Wales / Patient Compliance - statistics & numerical data / Pneumology / Polysomnography - instrumentation / Quality of Life / Respiratory system : syndromes and miscellaneous diseases / Severity of Illness Index / Sleep apnea / Sleep Apnea, Obstructive - complications / Sleep Apnea, Obstructive - physiopathology / Sleep Apnea, Obstructive - therapy / Treatment Outcome / Vascular Stiffness - physiology / Young Adult