Efficacy of a Novel Treatment Approach for Obstructive Sleep Apnea.

Objective: This study evaluates the efficacy of a novel approach to oral appliance therapy ("OAT") for the treatment of obstructive sleep apnea ("OSA"). This novel approach utilizes a systemized, oximetry-informed, treatment protocol and a precision-custom oral appliance. Methods: Sixty consecutive patients diagnosed with OSA were treated at Sleep Better Austin ("SBA") using a structured, multi-step protocol and a precision-custom oral appliance (ProSomnus EVO). Baseline and post-treatment apnea-hypopnea index ("AHI") values were compared using a matched-pair design. The primary outcome was the percentage of patients achieving a residual AHI of <10 events/h. Secondary outcomes included severity classification improvement. Results: In total, 90% of patients achieved the primary endpoint, and 87% improved by at least one severity classification. The mean AHI improved by 63% from baseline with the precision-custom OAT in situ (p < 0.001). In the moderate-to-severe subgroup, AHI improved by 70%, with 100% of severe patients achieving a residual AHI of <20 and a ≥50% improvement, without patient preselection. No serious adverse events were reported, and all patients continued therapy at follow-up. Conclusions: Precision-custom OAT, when delivered through a standardized clinical protocol informed by oximetry, can be a highly effective and well-tolerated treatment for OSA. These findings support its broader adoption as a non-invasive alternative to continuous positive airway pressure ("CPAP") and surgical interventions, particularly for patients seeking personalized, high-compliance solutions.