What question did this study set out to answer?

To report the effectiveness of a novel mandibular advancement device (MADArch) for treating obstructive sleep apnea (OSA) in a patient with a submucosal cleft palate.

May 10, 2026

1319 A Novel Mandibular Advancement Device with Palatal Arch Support (MADArch) for Treatment of Obstructive Sleep Apnea (OSA)

Key Points

To report the effectiveness of a novel mandibular advancement device (MADArch) for treating obstructive sleep apnea (OSA) in a patient with a submucosal cleft palate.
Case report of a 68-year-old male with severe OSA and a submucosal cleft palate.
Device created by oral and maxillofacial surgeon featuring palatal arch support.
Patient's apnea hypopnea index (AHI) and Epworth sleepiness scale (ESS) measured before and after MADArch use.
Before MADArch, the patient's AHI was 74/hour and ESS was 12/24, then normalized to 3.4/hour and ESS to 5/24 after device use.
Conventional MAD worsened residual AHI, indicating the MADArch's effectiveness in complex anatomical cases.
The device provided significant support for patients ineligible for other treatments like surgery.

Abstract

Abstract Introduction We report a case of refractory severe OSA with submucosal cleft palate who responded to our novel MADArch device, patent pending. This appliance may be an option for patients who are not candidates for conventional MAD for example edentulous patients, or who are not responsive to it for example submucosal cleft palate. Report of case(s) A 68-year-old man with elevated Epworth’s sleepiness scale (ESS) of 12/24 and severe OSA with apnea hypopnea index (AHI) of 74/hour was placed on PAP therapy. Initially, there was improvement of AHI to 3.4/hour, ESS to 5/24 (normal), but mask leak was high at 40.2L/min. After adding a conventional MAD for retrognathia, his mask leak improved. However, his ESS and residual AHI gradually increased again. Interestingly, his residual AHI was higher (37.7/hour) when using PAP therapy with the conventional MAD, rather than without it (AHI 6.7/hour). A PAP titration study with the conventional MAD showed severe residual OSA on maximal BiPAP ST (30/25 @ 12 bpm). CT chest showed no intrathoracic obstruction to explain the relapse of his OSA despite maximal PAP therapy and MAD. Drug-induced sleep endoscopy (DISE) revealed he had a bifid uvula with marked velopharyngeal collapse and invagination of the hard palate that rendered him ineligible for hypoglossal neurostimulator therapy, or even palatoplasty. CT sinuses confirmed a submucosal cleft palate. Of note, the patient was not interested in a tracheostomy to correct his OSA. The sleep provider devised a novel MAD featuring a palatal arch support (MADArch) and requested the patient’s oral and maxillofacial surgeon (OMFS) to create it. Using MADArch with BiPAP ST, normalized the patient’s AHI to 3.4/hour, and his ESS to 5/24. Conclusion This case highlights the efficacy of our novel MADArch appliance over conventional MAD in treating residual OSA in patients with extreme velopharyngeal collapsibility, due to conditions such as submucosal cleft palate, by providing structural support to the hard palate. Such innovations may offer viable alternatives to patients with complex palatal anatomy who are not surgical candidates or who prefer non-invasive treatment. Support (if any)

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