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Randomized Controlled Trial
. 2025 Aug 1;21(8):1425-1432.
doi: 10.5664/jcsm.11736.

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

Anna M Mohammadieh  1   2 , Benjamin K Tong  1   2 , Glenn M Stewart  1   2 , Philip de Chazal  1   3 , Peter A Cistulli  1   2
Affiliations
Randomized Controlled Trial

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

Anna M Mohammadieh et al. J Clin Sleep Med. .

Abstract

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

Methods: Patients established on MAD therapy for obstructive sleep apnea underwent 2 level 2 diagnostic polysomnography (PSG) studies with the smart MAD (sMAD) in situ, under 0 protrusion (control) and usual mandibular protrusion (treatment) conditions. The studies occurred within 2 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, and sleep position. An additional aim was to assess the ability of the device to detect the change in AHI across the 2 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 = .81, P < .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 2 (-12.7 ± 13.8 vs -6.9 ± 8.5 events/h for PSG and sMAD, respectively, P = .1). There was a high level of agreement for total sleep time in the combined control and treatment groups (r = .80, P < .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, total sleep time, adherence, 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.

Citation: Mohammadieh AM, Tong BK, Stewart GM, de Chazal P, Cistulli PA. Evaluation of a novel smart mandibular advancement device for nightly monitoring of treatment. J Clin Sleep Med. 2025;21(8):1425-1432.

Keywords: mandibular advancement; mandibular movements; sleep apnea; smart MAD.

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Conflict of interest statement

All authors have seen and approved the final manuscript. This study was performed at North Shore Health Hub, St Leonards (Sydney) and Royal North Shore Hospital, St Leonards (Sydney) and The Charles Perkins Centre at The University of Sydney, Australia. This is an industry-sponsored study designed by SomnoMed Australia. P.A.C. reports having an appointment to an endowed academic chair at The University of Sydney that was established from ResMed funding, has received research support from ResMed and SomnoMed, and is a consultant to SomnoMed, ResMed, Sunrise Medical, and Eli Lilly. A.M.M. has received in-kind research support from ResMed for investigator-initiated studies, and honoraria from SomnoMed for speaking at educational meetings. P.D.C. has worked as a consultant to SomnoMed for R&D related to the Rest Assure device. B.K.T. and G.M.S. have no conflicts of interest to declare.

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