Practitioners Approach to Oral Appliance Therapy for Obstructive Sleep Apnea and the Impact on Patients Outcomes - PROJECT SUMMARY/ABSTRACT Despite a plethora of published obstructive sleep apnea (OSA) management reports, little data exists regarding actual consensus among dental sleep medicine practitioners on the ideal oral appliance therapy (OAT) method for patients, treatment compliance, and impact on patient outcomes in a representative sample of OSA patients. Moreover, there is a need to understand titration protocols to help improve treatment success rates. We propose to conduct a clinical observational feasibility study within the South Texas Oral Health Network (STOHN) setting to examine dental practitioners' OAT titration methods for OSA and their OAT outcomes. The study will last 24 months. We will recruit practitioners over 12 months (N=10). Recruited practitioners and their trained office staff will identify patients coming in for an oral appliance (OA) delivery visit. They will approach consecutive eligible patients, describe the study, and obtain consent to participate in the study on the OA delivery visit. Patients (N=60; 6 patients per practitioner) will be enrolled. Following consent, at the baseline visit, the practitioner will deliver the custom-fabricated mandibular advancement device (MAD/OA) with an embedded compliance tracker chip (Dentitrac) to participants and give them a home sleep apnea testing (HSAT) device (NightOwl) with use instructions to record a baseline measure that evening without wearing the OA, followed by a baseline measure with the OA. Upon acclimatization, the participants will return within 4 weeks for an initial titration visit and within 8 weeks for a final titration visit (for a total of 3 data time points), where the practitioner will document their titration protocol and download compliance data from the MAD/OA. For each data timepoint, the patient will be instructed to use NightOwl for 3 consecutive nights in order to account for night-to-night variability. The average of the 3 nights will be recorded. The practitioner and participant-reported data will be collected via electronic data capture (REDCap). The pulmonologist (Dr. Prasad), a sleep physician, will read and interpret NightOwl data/report, and only the study investigators will have access to reports/data from all participants. At the end of the titration period/study, the practitioner will refer the participant to their sleep physician to verify the OA's effectiveness per their normal clinical protocol and per American Academy of Dental Sleep Medicine (AADSM) clinical guidelines. The study approach comprises a unique streamlined practice-based research network (PBRN) investigative process that prioritizes the feasibility of implementation and is well-suited to the Network (real-world practice) environment. The study will adhere to the principles of good clinical practice (GCP) concerning the standards for designing, conducting, recording, auditing, and reporting the study. Analysis of the data and successful completion of this study will help identify and describe current OAT best practices for OSA. Our goal is to identify opportunities to enhance care to impact the health and quality of life (QoL) of the many patients suffering from OSA. The successful completion of the study is anticipated to provide valuable insights into the treatment of OSA in current practice and foster strategies for future large-scale PBRN interventional studies.
