JMIR Publications

ABSTRACT

Background:

Oral appliance therapy (OAT) is a widely used treatment for obstructive sleep apnea (OSA); 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 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 OSA receiving OAT from 10 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 multi-method 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 (MDA), calculated as the product of physiologic efficacy (change in apnea–hypopnea index derived from multi-night 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 (IRB) approval from the University of Texas Health Science Center at San Antonio as the single reviewing IRB (STUDY00001750), with site-specific approval obtained from the University of Illinois Chicago (SITE00000057). As of manuscript submission, 7 practitioners have been enrolled and have initiated patient recruitment following training completed between December 2025 and February 2026. Patient enrollment is ongoing, with recruitment expected to continue through February 2027.

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.