ABSTRACT
RATIONALE: 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. OBJECTIVES: To compare health effects after 1 month of optimal CPAP and MAD therapy in OSA. METHODS: In this randomized crossover trial, we compared the effects of 1 month each of CPAP and MAD treatment on cardiovascular and neurobehavioral outcomes. MEASUREMENTS AND MAIN RESULTS: 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. CONCLUSIONS: 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).
Subject(s)
Automobile Driving , Continuous Positive Airway Pressure/statistics & numerical data , Mandibular Advancement/statistics & numerical data , Quality of Life , Sleep Apnea, Obstructive/therapy , Adult , Aged , Blood Pressure Monitoring, Ambulatory/instrumentation , Computer Simulation , Continuous Positive Airway Pressure/instrumentation , Continuous Positive Airway Pressure/methods , Cross-Over Studies , Fatigue/etiology , Fatigue/physiopathology , Female , Humans , Hypertension/etiology , Hypertension/physiopathology , Male , Mandibular Advancement/instrumentation , Mandibular Advancement/methods , Middle Aged , New South Wales , Patient Compliance/statistics & numerical data , Polysomnography/instrumentation , Severity of Illness Index , Sleep Apnea, Obstructive/complications , Sleep Apnea, Obstructive/physiopathology , Treatment Outcome , Vascular Stiffness/physiology , Young AdultABSTRACT
PURPOSE: Flow-volume curves have been shown to relate to upper airway physiology during sleep and may be useful for predicting the response to treatment of obstructive sleep apnea (OSA) with mandibular advancement splints (MAS). The aim of this study was to prospectively assess the potential clinical utility of a previously derived prediction method using flow-volume curves performed during wakefulness. METHODS: Patients with newly diagnosed OSA interested in undertaking treatment with a custom-made MAS were approached to participate in the study. Response to treatment was defined by a 50% or greater reduction in the apnea-hypopnea index. Flow-volume curves were performed in the erect position prior to construction of the MAS. RESULTS: Flow-volume curves were performed in 35 patients. Of these, 25 patients were responders, and 10 patients were non-responders. A combined cut-off of an inspiratory flow rate at 50% of vital capacity (MIF50) less than 6.0 L/s and a ratio of the expiratory flow rate at 50% of vital capacity to MIF50 of greater than 0.7 correctly classified 48.6% of the patients. It had a sensitivity of 36.0%, specificity of 80.0%, positive predictive value of 81.8%, and negative predictive value of 33.3%. CONCLUSIONS: These results suggest that the previously derived prediction model, using flow-volume curves performed during wakefulness, was not sufficient to reliably predict the response to treatment of OSA with MAS. A combination of a functional assessment using flow-volume curves and a structural evaluation of the upper airway with imaging modalities may result in a prediction model with better performance characteristics.
