Evaluation of a novel smart mandibular advancement device for nightly monitoring of treatment.

Abstract

Study objectives: Study Objectives: A current gap in oral appliance therapy, relative to continuous positive airway pressure, in the management of obstructive sleep apnea (OSA) is access to nightly therapy data. The aim of this pilot study was to evaluate the performance of a novel intra-oral, multi-sensory array embedded within a mandibular advancement device (MAD).

Methods: Patients established on MAD therapy for OSA underwent two level 2 diagnostic polysomnography (PSG) studies with the smart MAD (sMAD) in situ, under zero protrusion (control) and usual mandibular protrusion (treatment) conditions. The studies occurred within two weeks of one another, and the sequence of studies was randomly allocated. The agreement between sMAD and PSG was assessed using apnea-hypopnea index (AHI), total sleep time (TST), and sleep position. An additional aim was to assess the ability of the device to detect the change in AHI across the two conditions (control vs treatment).

Results: Overall, there was a high level of agreement between sMAD and PSG in the treatment condition with regards to the AHI (r = 0.81, p<0.001). Both PSG and sMAD detected a significant change in AHI associated with mandibular advancement in the treatment condition relative to control, and this change was not significantly different between the two (-12.7 ± 13.8 vs -6.9 ± 8.5 events/h for PSG and sMAD respectively, p=0.1). There was a high level of agreement for total sleep time in the combined control and treatment groups (r = 0.80, p<0.001). Sleep position showed high concordance in the lateral position (98%), but supine sleep showed moderate concordance (64%) related to differences in position monitoring between sMAD and PSG (ie. head vs torso).

Conclusions: This pilot study demonstrates the feasibility of estimating clinically relevant therapy data with high accuracy from a sensor system within a MAD. The ability to provide clinicians with relevant sleep metrics including AHI, TST, compliance, sleep position and response to MAD therapy on a nightly basis has the potential to enhance clinical uptake of MAD therapy. Further research is required to validate these results in a larger sample over a longer term.