AbstractIntroductionOral appliance therapy (OAT) is used for the treatment of obstructive sleep apnea in mild to moderate patients. First-time fit is important for treatment burden and dental economics. This prospective, “real-world” collaborative (physician/dentist) study will assess the primary endpoint of at least a 50% reduction in baseline apnea-hypopnea index (AHI) at five years. Additionally, this study will assess fit during initial delivery. The Panthera D-SAD is a CAD/CAM, 3D-printed OAT. Updated design and comfort features have been integrated. Changeable rods (mechanical hinge) provide the mechanism for protrusion. This study fulfills French reimbursement requirements.MethodsOAT naïve individuals with moderate OSA (AHI 15-30) or those with severe OSA (AHI 30 or greater) who decline CPAP will be included, meeting all other criteria. An estimated 337 participants will be enrolled at 11 centers in France. Consecutive sampling will be used. Participants will be medically assessed, a prescription for OAT obtained, dental assessment and then, the initial fitting will be at Visit 1 (V1). Standard of care for the study duration will be followed. Evaluation time points are three months (medical), six months (dental), two years (both), and five years (both). Secondary endpoints include OAT side effects, oxygen desaturation indices, quality of life, self-reported adherence, and subjective symptoms at the aforementioned time pointsResultsTo date, a total of 56 subjects have been enrolled. This report is focused on the 24 subjects who have had V1, OAT fit, and titration visits. The demographics are as follows:(F=8); Averages (and standard deviation) for the following are age 51.2 (1.5).; baseline AHI of 20.5 (6.07); ODI 14.71(8.9); SpO2 93.46 (1.06), BMI 25.73 (3.13), and rod length of 26.6mm (1.05). 91.6% of dentists reported at V1 that no rod changes were required. 82.6% of patients indicated the OAT was comfortable, three patients had dental or muscle pain, and one, the device was too tight.ConclusionV1 is a crucial step in the therapeutic journey. This early data demonstrate a high OAT acceptance rate for dentists and patients while reducing the time required for first-time fit, thus lowering practitioner and patient burden and costs.Support (if any)Panthera Dental Inc, Quebec City, Quebec Canada