The South Texas Oral Health Network Study of Practitioners' Approaches to Oral Appliance Therapy Titration for Obstructive Sleep Apnea and Their Impact on Patient Outcomes (PAOSA): Protocol for a Prospective Observational Study.

Background: Oral appliance therapy (OAT) is a widely used treatment for obstructive sleep apnea; however, titration approaches remain variable and lack standardization across clinical practice. Existing evidence is largely derived from academic or specialty sleep centers, with limited data on how titration strategies are implemented and perform in real-world dental settings. Objective: This study aims to evaluate real-world titration approaches for OAT within a dental practice-based research network and to assess their impact on treatment effectiveness and patient-centered outcomes. Methods: This prospective, multisite, observational feasibility study will enroll approximately 60 adult patients with physician-diagnosed obstructive sleep apnea receiving OAT from 10 dental practitioners within the South Texas Oral Health Network, with each practitioner enrolling up to 6 patients. Practitioners will apply either standard signs-and-symptoms-based titration or enhanced multimethod positioning titration, as per their usual clinical practice. Clinical, dental, and titration characteristics will be collected at baseline and follow-up visits over an approximately 8-week titration period. The primary outcome is mean disease alleviation, calculated as the product of physiologic efficacy (change in apnea-hypopnea index derived from multinight home sleep apnea testing) and objective adherence (hours of nightly oral appliance use captured via an embedded compliance tracker). Secondary outcomes include daytime sleepiness, sleep-related quality of life, patient satisfaction, oral appliance-related side effects, and bruxism. Descriptive analyses and generalized estimating equation models will be used to account for clustering of patients within practitioners. Results: The study was funded on June 17, 2025, and received Institutional Review Board approval from the University of Texas Health Science Center at San Antonio as the single reviewing Institutional Review Board (STUDY00001750), with site-specific approval obtained from the University of Illinois Chicago (SITE00000057). Study start-up activities, including development of data systems and coordination with device vendors, were completed between September and December 2025. Practitioner training was conducted between December 2025 and February 2026. As of March 2026, 7 dentists have been enrolled and have initiated patient recruitment. Participant recruitment began in late 2025 and is projected to continue through January 2027. Data analysis is anticipated in 2027, with study findings expected to be disseminated thereafter. Conclusions: This study will generate preliminary, real-world evidence on oral appliance titration strategies and their relationship to treatment effectiveness and patient outcomes in community dental practices. Findings will inform the design of future interventional trials and support the development of evidence-based guidance for OAT titration.