0548 A 5-year Multi-center Real-world Study Evaluating the Effectiveness and Use of CAD/CAM 3D-printed OAT to Treat OSA

Abstract Introduction Oral appliance therapy (OAT) treats a wide range of obstructive sleep apnea (OSA). This prospective, collaborative (physician/dentist) study will assess the primary endpoint of at least a 50% reduction in baseline apnea-hypopnea index (AHI) at five years with initial objective efficacy evaluation at three to six months. The Panthera D-SAD is a CAD/CAM, 3D-printed OAT. Patient- matched for fit and comfort. Changeable rods provide the mechanism for protrusion. This study fulfills French reimbursement requirements. Methods OAT naïve individuals with an AHI 15-30 or those with an AHI ≥ 30 who decline CPAP will be considered, meeting all other entry criteria. Fifteen centers in France will enroll an estimated 217 participants. Consecutive sampling will be used. Participants will be medically and dentally evaluated. The initial fitting will be at Visit 1 (V1). Standard of care for the study duration will be followed. Evaluation time points are three-six months (sleep testing/medical), six months (dental), and five years (both). Secondary endpoints include OAT side effects, oxygenation status, quality of life, self-reported adherence, and subjective symptoms at the aforementioned time points. Results Between April, 2022, and December, 2023, 171 subjects have had their sleep and orthosis evaluation for entry into the study (V0). The demographics for those who have completed V0 (n=171): averages (SD) age 49.7 (13.0); BMI 26.75 (4.81); baseline AHI of 22.2 (8.7), ODI 17.16 (11.92), SpO2 91.7 (2.18). This update summarizes data from the subset (n=76) with sleep testing (V2). At baseline, 92% of participants had moderate OSA. Sixty-three percent of all participants achieved at least a 50% AHI reduction. Sixty-two percent achieved an AHI 10. At V2, 84% severe and 87% moderate transitioned to a lower severity category. For moderate, 21% reached the normal category. Eighty-seven percent reported weekly use at V2 (n=62) for seven nights/week, and 97% indicated they used the device for ≥ 4 hours a night. Only 2.3% of participants stopped wearing the device. Conclusion This updated data demonstrates a high OAT acceptance and comfort rate for patients. Preliminary data are tracking well for reducing total AHI and migrating to a less severe AHI category. Support (if any) Panthera Dental Inc