Long-Term Objective Adherence to Mandibular Advancement Device Therapy Versus Continuous Positive Airway Pressure in Patients With Moderate Obstructive Sleep Apnea.

STUDY OBJECTIVES: Comparable health effects of mandibular advancement device (MAD) and continuous positive airway pressure (CPAP) therapy have been attributed to higher adherence with MAD compared with CPAP therapy. The objective of this study was to make a direct comparison of the objective adherence between MAD and CPAP in patients with moderate obstructive sleep apnea (OSA). METHODS: Adherence was monitored for 12 months in 59 patients with moderate OSA (apnea-hypopnea index 15-30 events/h) as part of a randomized controlled trial. Objective adherence with MAD was assessed using the TheraMon microsensor. Objective adherence with CPAP was assessed using the built-in registration software with readout on SD card. Self-reported adherence with both therapies was assessed using a questionnaire. RESULTS: Forty patients (68%) completed the study with the therapy to which they were randomly assigned. Median (interquartile range) objective adherence (h/night) in the 3rd month was 7.4 (5.2-8.2) for MAD and 6.8 (5.7-7.6) for CPAP (P = .41), compared to 6.9 (3.5-7.9) with MAD and 6.8 (5.2-7.6) with CPAP (P = .85) in the 12th month. There were no significant changes between the 3rd and 12th month for both MAD (P = .21) and CPAP (P = .46). Changes in adherence were not significantly different between MAD and CPAP (P = .51). Self-reported adherence was significantly higher with MAD than CPAP at all follow-ups. Self-reported adherence with CPAP was lower than objective CPAP adherence at the 6th and 12th month (P = .02). CONCLUSIONS: Objective adherence with MAD and CPAP is comparable and consistent over time. Self-reported adherence is higher with MAD than with CPAP giving rise to interesting discrepancy between objective and self-reported adherence with CPAP. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Identifier: NCT01588275.

Clinical- and Cost-Effectiveness of a Mandibular Advancement Device Versus Continuous Positive Airway Pressure in Moderate Obstructive Sleep Apnea.

STUDY OBJECTIVES: Limited evidence exists on the cost-effectiveness of mandibular advancement device (MAD) compared to continuous positive airway pressure (CPAP) therapy in moderate obstructive sleep apnea (OSA). Therefore, this study compares the clinical and cost-effectiveness of MAD therapy with CPAP therapy in moderate OSA. METHODS: In a multicentre randomized controlled trial, patients with an apnea-hypopnea index (AHI) of 15 to 30 events/h were randomized to either MAD or CPAP. Incremental cost-effectiveness and cost-utility ratios (ICER/ICUR, in terms of AHI reduction and quality-adjusted life-years [QALYs, based on the EuroQol Five-Dimension Quality of Life questionnaire]) were calculated after 12 months, all from a societal perspective. RESULTS: In the 85 randomized patients (n = 42 CPAP, n = 43 MAD), AHI reduction was significantly greater with CPAP (median reduction AHI 18.3 [14.8-22.6] events/h) than with MAD therapy (median reduction AHI 13.5 [8.5-18.4] events/h) after 12 months. Societal costs after 12 months were higher for MAD than for CPAP (mean difference €2.156). MAD was less cost-effective than CPAP after 12 months (ICER -€305 [-€3.003 to €1.572] per AHI point improvement). However, in terms of QALY, MAD performed better than CPAP after 12 months (€33.701 [-€191.106 to €562.271] per QALY gained). CONCLUSIONS: CPAP was more clinically effective (in terms of AHI reduction) and cost-effective than MAD. However, costs per QALY was better with MAD as compared to CPAP. Therefore, CPAP is the first-choice treatment option in moderate OSA and MAD may be a good alternative. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Identifier: NCT01588275.