App-Based Myofunctional Therapy to Improve Adherence and Outcomes of Mandibular Advancement Devices in Moderate Obstructive Sleep Apnea: Multicenter Randomized Trial Protocol.

BACKGROUND

Mandibular advancement devices (MADs) are a valid alternative for patients with moderate obstructive sleep apnea (OSA) who do not tolerate continuous positive airway pressure. Despite their efficacy, both adherence and long-term results remain a challenge. Myofunctional therapy (MT) has shown potential to improve upper airway muscle tone and reduce OSA severity, but its role as an adjunct to MAD treatment is still unclear. This protocol evaluates whether app-based MT (Airway Gym) can improve adherence and clinical outcomes in patients with moderate OSA treated with MADs. We describe the study design.

OBJECTIVE

This study aims to evaluate whether a mobile app-based MT program (Airway Gym) can improve adherence to MAD therapy and related sleep parameters in patients with moderate OSA treated with MADs.

METHODS

This multicenter, prospective, randomized, controlled study included adults aged 18-75 years with moderate OSA (apnea-hypopnea index 15-30). Participants were randomized into four groups: (1) placebo exercises, (2) MT only, (3) MAD only, and (4) MAD plus MT. Outcomes included changes in the apnea-hypopnea index, oxygen desaturation index, sleep quality (Epworth and Pittsburgh scores), and tongue strength/endurance measured with the Iowa Oral Performance Instrument and a tongue digital spoon. Adherence was monitored via telemedicine and sleep diaries.

RESULTS

Recruitment began in February 2024 across participating centers. Data collection was planned to continue until December 2025, after which the final analyses were performed. The protocol described the study procedures up to the most recent administrative review conducted in January 2025.

CONCLUSIONS

This protocol describes the rationale and methodology of a randomized trial evaluating app-based MT as an adjunct to MAD therapy in patients with moderate OSA. Full study results will be reported after the final analysis.