This is a prospective, multisite, observational feasibility study to evaluate real-world titration strategies for OAT in OSA. The study examines two titration approaches defined by the American Academy of Dental Sleep Medicine (AADSM) (Figure 1): (1) standard signs-and-symptoms–based titration and (2) enhanced multimethod positioning, which incorporates objective physiologic measures such as pulse oximetry or HSAT. Both approaches are implemented as part of routine clinical care. This study is a nonrandomized, observational investigation designed to evaluate differences in treatment effectiveness between standard signs-and-symptoms–based titration and enhanced multimethod positioning approaches. A clustered design is used, with patients nested within dentists, reflecting real-world clinical practice. Participating dentists who use both titration approaches will apply their usual method for the first 3 enrolled patients and will subsequently be asked to use the alternate approach for the remaining patients, allowing for within-practitioner comparisons. Dentists who routinely use only one titration method will continue to apply that approach consistently across all enrolled patients. For each patient, the selected titration approach is maintained throughout the titration period.

A total of 60 patients (approximately 6 per dentist) will be enrolled across 10 participating dentists over a 24-month study period, with a planned allocation favoring the enhanced titration approach to support feasibility assessment. Oral appliance therapy is delivered using MADs within routine care, with clinicians retaining discretion over device selection and design features. No protocol-driven training or mandated switching between approaches is imposed, and clinicians continue to follow their usual clinical practices. While this design enhances ecological validity, it may introduce variability related to practitioner and patient factors. These will be addressed analytically through adjustment for measured confounders and the use of generalized estimating equation models to account for clustering of patients within dentists. As a feasibility study, the primary focus is on recruitment, retention, data completeness, protocol adherence, and estimation of preliminary effect sizes to inform future interventional trials. This study protocol is reported using a structured format aligned with STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines for observational studies [26].

The study is conducted within the STOHN, a regional dental practice–based research network comprising approximately 379 members across private practices, community-based clinics (eg, Federally Qualified Health Centers), and academic or faculty practice settings. Eligible practitioners must meet the following criteria: (1) be a licensed dentist (general dentist or specialist) and a current member of STOHN; (2) be qualified in dental sleep medicine (DSM), as demonstrated through prior training, continuing education, or clinical experience in managing patients with OSA; (3) have treated at least 3 patients with physician-diagnosed OSA using OAT within the past 12 months; (4) complete required human subjects protection training and study-specific training prior to patient enrollment; (5) agree to apply a defined titration approach consistently to all enrolled patients. Dentists from a range of practice settings are eligible, with no restrictions on practice type. Both general dentists and dental specialists may participate. Exclusion criteria for practitioners include participation of more than one dentist from the same practice site to minimize potential inter-dentist contamination.

Dentists from the Southwest Region of the National Dental -PBRN (n=1678) were invited to participate. In addition, the study’s principal investigators encouraged eligible colleagues within the National Dental PBRN, including those outside the Southwest Region, to participate. Eligibility criteria were consistently applied to all invited practitioners.

The study is coordinated by the University of Texas Health Science Center at San Antonio (UTHSA) Clinical Research Informatics/Data Coordinating Center and supported by Clinical and Translational Science Award infrastructure. Participating practices serve as recruitment and data collection sites. Dentist enrollment has been initiated, and patient enrollment is ongoing at the time of manuscript submission. The anticipated study duration is 24 months.

The study population comprises adult patients receiving OAT for OSA in participating dental practices within the STOHN. Eligible participants must meet the following criteria: (1) be aged 18 years or older; (2) have a confirmed diagnosis of OSA established by a qualified sleep physician; (3) have a referral for OAT with a scheduled oral appliance delivery visit at a participating site; (4) be able to communicate in English; (5) have access to email or text messaging for study communication; (6) be willing to complete HSAT using the NightOwl device [16,17]; (7) agree to use an oral appliance embedded with an objective compliance tracker (DentiTrac) [15].

Participants will be excluded if they: (1) lack a physician-confirmed diagnosis of OSA;

(2) have a history of OSA-related surgical treatment (eg, tonsillectomy and/or adenoidectomy or uvulopalatopharyngoplasty [UPPP]); (3) are unable to provide reliable contact information; and (4) decline participation in device-based monitoring. Participants are recruited consecutively from eligible patients receiving routine clinical care at participating sites. The titration approach is determined by the treating practitioner and applied consistently to enrolled patients within each practice.

Participating dentists will enroll eligible patients and obtain consent during routine clinical care at the time of dental examination and oral appliance prescription, with consent confirmed at the appliance delivery visit following study onboarding and training. Standardized study materials, including binders with detailed workflow diagrams (Figure 2), data collection guidance, and Research Electronic Data Capture (REDCap; Vanderbilt University) data entry forms, have been developed to support integration of study procedures into routine practice and ensure consistent data collection using REDCap, NightOwl, and DentiTrac devices. An enrollment log is maintained at each site to document screening, eligibility, enrollment, and reasons for nonparticipation.

The study team and STOHN network coordinator provide ongoing support, including protocol guidance, troubleshooting, and monitoring of recruitment progress. Dentist engagement is supported through regular communication, standardized materials, periodic recruitment updates, and continuing education opportunities. Patient retention is facilitated through reminder emails, a text messaging system (short message service, SMS), telephone follow-ups, and flexible scheduling to minimize participant burden and support continued participation.

The study includes three study visits conducted during an approximately 8-week titration period (10 days). At visit 1a (screening and consent), eligibility is confirmed, electronic informed consent is obtained, and baseline dental examinations and clinical assessments are completed. At visit 1b (baseline), consent is confirmed, the oral appliance is delivered, baseline questionnaires are administered, and participants initiate HSAT monitoring. Follow-up assessments are conducted. at approximately 4 weeks (visit 2) and 8 weeks (visit 3). At visit 2 (4-week follow-up [10 days]), dentists perform titration adjustments as needed, collect adherence data, and have participants complete follow-up questionnaires and HSAT monitoring. At visit 3 (8-week follow-up [10 days]), final titration is performed if needed, and final adherence data, patient-reported outcomes, and HSAT assessments are collected. Following completion of study procedures, participants return to their sleep physician as part of routine clinical care.

All study data will be entered into a secure REDCap system managed by the CRI Division at UT Health San Antonio, with built-in validation checks to ensure data quality and consistency. Dentist-reported, patient-reported, and device-generated data are integrated and linked using unique participant identifiers. As illustrated in Figure 3, data originate from multiple sources, including REDCap entry, NightOwl HSAT, and DentiTrac compliance systems, and are centralized through coordinated manual and automated data flows. Data are encrypted during transmission, stored on secure servers, deidentified for analysis, and tracked with audit trails. Ongoing data quality is maintained through centralized monitoring, routine checks for missing or inconsistent data, and resolution of discrepancies in collaboration with participating sites. Monitoring activities include remote data review and evaluation of recruitment, retention, and protocol adherence to ensure compliance with regulatory standards. This study is minimal risk. Safety monitoring focuses on unanticipated problems or adverse events related to study participation. Principal investigators conduct quarterly safety reviews, and all reportable events are submitted to the UTHSA Institutional Review Board (IRB) in accordance with institutional policy.

Study findings will be disseminated through peer-reviewed publications, presentations at national and international scientific meetings, and communication with participating practitioners through practice-based research network channels to support translation into clinical practice. Authorship will follow the International Committee of Medical Journal Editors guidelines, and participating dentists will be acknowledged as part of the study network. Deidentified data underlying study findings, along with associated documentation, will be made available following publication in accordance with UTHSA institutional policies and applicable data-sharing requirements. Data will be stored in secure repositories in accordance with regulatory and funding agency (National Institute of Dental and Craniofacial Research) guidelines. Any protocol amendments, including modifications to study procedures or early termination, will be reviewed and approved by the UTHSA IRB and documented in accordance with institutional and regulatory requirements.

The study will be conducted in accordance with International Council for Harmonization guidelines, the Code of Federal Regulations for the Protection of Human Subjects (45 CFR 46), and applicable National Institutes of Health policies. The IRB approval was obtained from the UTHSA as the single reviewing IRB (STUDY00001750). Site-specific approval was also obtained from the University of Illinois Chicago IRB (SITE00000057). Any protocol modifications will be submitted to the IRB for approval prior to implementation and communicated to participating sites. Electronic informed consent will be obtained at visit 1a by trained personnel. Participants will receive detailed information about study procedures, risks, and benefits, and will have the opportunity to ask questions. Confidentiality will be maintained through unique study identifiers, secure systems, and restricted data access. Dentists will receive US $80 per enrolled patient. Participants will receive US $60 total (US $20 per study visit) to compensate for time and participation. All investigators will disclose potential conflicts of interest, which will be reviewed and managed in accordance with institutional policies.

This study is designed to generate feasibility data and preliminary real-world evidence comparing 2 commonly used oral appliance titration strategies and their impact on adherence-adjusted treatment effectiveness and patient-centered outcomes. Specifically, we anticipate that integrating objective physiologic monitoring into titration (enhanced multimethod positioning) may improve MDA by optimizing both treatment efficacy and adherence.

Prior studies of OAT consistently demonstrate that treatment effectiveness is shaped not only by physiologic efficacy but also by adherence, tolerability, and patient experience. Comparative effectiveness research in sleep medicine has shown that when adherence [32] is incorporated into outcome assessment, oral appliances may achieve patient-centered outcomes comparable to CPAP despite lower reductions in AHI [7,14,33,34].

Evidence evaluating oral appliance titration strategies remains limited. Existing studies have largely focused on academic or specialty sleep centers, with relatively small samples and limited integration of objective adherence data or repeated physiologic monitoring [11,13,25]. Although the AADSM recognizes both signs-and-symptoms–based titration and multimethod positioning approaches, available data do not clearly establish the comparative effectiveness of these strategies in practice-based settings [12,13]. As a result, titration practices remain heterogeneous, driven largely by clinician preference, workflow constraints, and patient tolerance rather than evidence-based guidance.

Several dentistry-focused studies provide insight into how treatment-delivery factors influence outcomes [35]. Comparative evaluations of MAD designs demonstrate that improvements in symptoms, comfort, and patient-reported outcomes may vary substantially even when reductions in respiratory indices are similar [36]. These findings suggest that physiologic response alone may not adequately capture real-world effectiveness, and that titration approach, device characteristics, and patient experience may play meaningful roles in sustained treatment benefit.

Side effects and tolerability further influence adherence and effectiveness. Prior comparisons of MAD and tongue-stabilizing devices indicate similar improvements in respiratory event indices, but markedly different acceptance rates and patient-reported outcomes [37]. In these studies, lower acceptance and higher discontinuation rates were associated with reduced quality of life gains, reinforcing the importance of integrating patient experience into treatment evaluation. Collectively, these findings support the need for outcome measures that account for both efficacy and real-world use, particularly when comparing titration strategies that may differentially affect comfort, side effects, and adherence.

International consensus guidance published in 2024 further highlights persistent uncertainty regarding optimal OAT implementation. Although multidisciplinary collaboration between sleep physicians and dental providers is strongly endorsed, consensus statements acknowledge substantial variability in titration practices and limited evidence on how titration should be operationalized across diverse clinical settings [38,39]. The absence of standardized, evidence-based titration pathways outlined in these recommendations underscores the need for practice-based research evaluating how titration is delivered in routine care, particularly outside academic environments.

Long-term dental side effects associated with MAD further emphasize the importance of titration and monitoring strategies. A recent systematic review and meta-analysis demonstrated progressive dental changes over time, including reductions in overjet and overbite and alterations in incisor inclination, while skeletal effects remained minimal [40]. These findings suggest that mandibular advancement represents cumulative exposure and that its magnitude and duration may influence dental outcomes. Objective adherence data, when interpreted alongside physiologic response, provide important context for balancing airway benefit with dental tolerability and may support more individualized titration decisions over time.

Strengths of this study include its PBRN design, integration of objective physiologic and adherence data, and evaluation of titration strategies within routine clinical workflows. The PBRN design is a major strength of this study. PBRNs provide a validated infrastructure for evaluating clinical care in real-world settings across diverse populations and practice models [19-21]. Conducted within the STOHN and in collaboration with the National Dental PBRN, PAOSA reflects the heterogeneity of real-world dental practice and enhances the external validity and applicability of study findings [25].

Several limitations should be considered. The observational, nonrandomized design introduces the potential for residual confounding and selection bias, although the structured within-practitioner approach was implemented to reduce between-practitioner variability. The relatively short follow-up period focuses on early treatment response and may not capture long-term adherence patterns or dental changes. In addition, eligibility requirements related to language and device use may limit participation among some populations. These limitations are appropriate for a feasibility-focused study and are expected to inform the design of subsequent interventional trials. As a feasibility protocol, PAOSA is designed to generate critical data on recruitment, retention, data completeness, protocol adherence, and preliminary effect-size estimates to support future randomized or pragmatic trials. The study will also identify practical barriers and facilitators to integrating HSAT and objective adherence monitoring into routine dental workflows, both of which are essential for scalability and sustainability.

Future directions include the development of randomized or hybrid effectiveness-implementation trials to more definitively evaluate titration strategies, as well as expansion to broader populations and longer follow-up periods. Study findings will be disseminated through peer-reviewed publications, presentations at scientific meetings, and communication within the dental practice–based research network to support translation into clinical practice.

This study will generate feasibility data and preliminary real-world evidence on oral appliance titration strategies in routine dental practice. This study addresses a critical gap in OSA management by generating real-world, adherence-adjusted evidence on oral appliance titration across diverse dental practice settings. By integrating objective physiologic and adherence measures, the study moves beyond traditional efficacy metrics to capture clinically meaningful treatment effectiveness. The findings will provide a foundation for evidence-based titration guidance, inform the design of future interventional trials, and support more personalized, patient-centered approaches to optimizing oral appliance therapy for OSA.