Efficacy of a Novel Treatment Approach for Obstructive Sleep Apnea

Objective: This study characterizes the efficacy of a novel approach to oral appliance therapy for the treatment of obstructive sleep apnea. This approach utilizes a systemized, repeatable, treatment protocol and a precision-custom oral appliance. Methods: Sixty patients diagnosed with OSA were treated at Sleep Better Austin 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 < 10 events/hour. Secondary outcomes included severity classification improvement. Results: Ninety percent 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 < 20 and ≥50% improvement without preselection such as drug induced sleep endoscopy. 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, can be a highly effective and well-tolerated treatment for OSA. These findings support its broader adoption as a non-invasive alternative to CPAP and surgical interventions, particularly for patients seeking personalized, high-compliance solutions.