Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 11, 2025
Open Peer Review Period: Aug 1, 2025 - Sep 26, 2025
Date Accepted: Nov 25, 2025
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
App-Based Myofunctional Therapy to Improve Adherence and Outcomes of Mandibular Advancement Devices in Moderate OSA: A Multicenter Randomized Trial with Preliminary Results
ABSTRACT
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 (CPAP). 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 myofunctional therapy (Airway Gym®) can improve adherence and clinical outcomes in patients with moderate obstructive sleep apnea (OSA) treated with mandibular advancement devices (MADs). We describe the study design and present preliminary data from the first 25% of enrolled participants.
Objective:
To evaluate whether a mobile app-based MT program (Airway Gym®) can improve adherence and clinical outcomes 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 [AHI] 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 AHI, oxygen desaturation index (ODI), sleep quality (Epworth and Pittsburgh scores), and tongue strength/endurance measured with the Iowa Oral Performance Instrument (IOPI) and a tongue digital spoon. Adherence was monitored via telemedicine and sleep diaries. Preliminary results from the first 25% of participants are presented.
Results:
Twelve participants (25% of the planned cohort) completed the 3-month follow-up. The MAD+MT group showed the greatest improvement in AHI (−58%) and reported 100% adherence. This group also reported lower discomfort (VAS 1.2 vs 3.1) and greater gains in tongue strength. No adverse events were observed. These preliminary findings support the feasibility and potential benefit of the combined intervention.
Conclusions:
Early results suggest that app-based MT may enhance adherence and effectiveness of MAD therapy for moderate OSA. Integrating digital MT could optimize treatment outcomes in selected patients, and full study results will confirm these promising trends. Clinical Trial: ISRCTN13128082; https://www.isrctn.com/ISRCTN13128082
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