Efficacy of a Novel Treatment Approach for Obstructive Sleep Apnea
<b>Objective</b>: 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. <b>Methods</b>: 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. <b>Results</b>: 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 (<i>p</i> < 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. <b>Conclusions</b>: 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.
Authors
- Erin Mosca
- Gilles Besnainou
- Mary Margaret Kerr (ORCID: https://orcid.org/0000-0002-2082-8812)
- Len Liptak
- P. A. Neal
- Jenny Tran (ORCID: https://orcid.org/0000-0002-1774-8803)
- B. Ch. J. Sutter
- Brandon Hedgecock
Institutions
- Carl R. Darnall Army Medical Center (US)
- Hôpital Lariboisière (FR)
- Sleep Therapy and Research Center (US)
Publication Details
- Journal
- Biomedicines
- Published
- 2025-10-02
- DOI
- https://doi.org/10.3390/biomedicines13102413
- Primary Topic
- Obstructive Sleep Apnea Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00