Abstract

Study objectives: Could a clinically safe and reliable compliance measure of mandibular advancement appliance (MAA) therapy demonstrate a high level of therapeutic efficacy, in patients diagnosed with moderate OSAHS. Study design and participants: A long-term prospective observational study was undertaken in which patients with moderate OSAHS and in whom CPAP use had failed, to determine treatment compliance with MAA therapy, after a minimum period of 18 months, using an objective monitor. Treatment outcomes included both objective sleep monitoring and a determination of the therapeutic efficacy based on the calculation of the mean disease alleviation (MDA). Results: Forty-two patients, with moderate OSAHS (mean AHI of 21.0 [+/- 10.3] events/hour) completed the study, at 18-month follow-up. A statistically significant difference (p < 0.001; 95% CI 2.76, 3.50) was observed between the objectively recorded use of the MAA appliance (7.13 hours) and the predetermined gold standard level of 4 hours. A highly statistically significant reduction (p < 0.001) was observed in follow-up ESS (7.2 +/- 3.3) and AHI (4.7 +/- 3.0) scores, which in turn was evidenced by the calculated therapeutic efficacy of 75.1% (95 CI 70.9, 79.2) and a MDA of 70% (95 CI 63.7, 76.3). Conclusion: The study demonstrates the safe long-term objective measurement of compliance and comparable levels of therapeutic efficacy for MAA therapy in patients with moderate OSAHS, providing new evidence of the role of MAA therapy as a viable alternative in patients unable to tolerate CPAP.

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