{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T03:47:56Z","timestamp":1787024876198,"version":"build-2736575974"},"reference-count":32,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Res Protoc"],"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n This study aims to evaluate whether a mobile app\u2013based MT program (Airway Gym) can improve adherence to MAD therapy and related sleep parameters in patients with moderate OSA treated with MADs.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n This multicenter, prospective, randomized, controlled study included adults aged 18\u201075 years with moderate OSA (apnea\u2013hypopnea index 15\u201030). 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\u2013hypopnea 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.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>","DOI":"10.2196\/80521","type":"journal-article","created":{"date-parts":[[2025,11,25]],"date-time":"2025-11-25T09:10:05Z","timestamp":1764061805000},"page":"e80521-e80521","source":"Crossref","is-referenced-by-count":1,"title":["App-Based Myofunctional Therapy to Improve Adherence and Outcomes of Mandibular Advancement Devices in Moderate Obstructive Sleep Apnea: Multicenter Randomized Trial Protocol"],"prefix":"10.2196","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-9772-9333","authenticated-orcid":false,"given":"Juan Antonio","family":"Iba\u00f1ez-Rodr\u00edguez","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1670-4235","authenticated-orcid":false,"given":"Carlos","family":"O'Connor-Reina","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-5742-2282","authenticated-orcid":false,"given":"Ricardo","family":"Lucas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5148-5111","authenticated-orcid":false,"given":"Laura","family":"Rodriguez-Alcala","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6141-5360","authenticated-orcid":false,"given":"Eduardo","family":"Correa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7806-1629","authenticated-orcid":false,"given":"Jose Maria","family":"Ignacio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-7829-8216","authenticated-orcid":false,"given":"Patricia","family":"Fernandez-Sanjuan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2366-6919","authenticated-orcid":false,"given":"Peter","family":"Baptista","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6409-4921","authenticated-orcid":false,"given":"Guillermo","family":"Plaza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2025,12,19]]},"reference":[{"issue":"8","key":"R1","doi-asserted-by":"publisher","first-page":"687","DOI":"10.1016\/S2213-2600(19)30198-5","article-title":"Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis","volume":"7","author":"Benjafield","journal-title":"Lancet Respir Med"},{"issue":"2","key":"R2","doi-asserted-by":"publisher","DOI":"10.1007\/s11325-025-03317-z","article-title":"A comparative study on the hemodynamic effects of initiating positive airway pressure treatment in patients with obstructive and central sleep apnea","volume":"29","author":"M\u00fcller","journal-title":"Sleep Breath"},{"issue":"6","key":"R3","doi-asserted-by":"publisher","first-page":"613","DOI":"10.1001\/jama.2011.1115","article-title":"Sleep-disordered breathing, hypoxia, and risk of mild cognitive impairment and dementia in older women","volume":"306","author":"Yaffe","journal-title":"JAMA"},{"issue":"2","key":"R4","doi-asserted-by":"publisher","first-page":"173","DOI":"10.1513\/pats.200708-119MG","article-title":"Adherence to continuous positive airway pressure therapy: the challenge to effective treatment","volume":"5","author":"Weaver","journal-title":"Proc Am Thorac Soc"},{"issue":"6","key":"R5","doi-asserted-by":"publisher","first-page":"2501","DOI":"10.1007\/s11325-024-03134-w","article-title":"Mandibular device treatment in obstructive sleep apnea - a structured therapy adjustment considering night-to-night variability night-to-night variability in mandibular devices","volume":"28","author":"Papenfu\u00df","journal-title":"Sleep Breath"},{"issue":"2","key":"R6","doi-asserted-by":"publisher","first-page":"215","DOI":"10.5664\/jcsm.3460","article-title":"Oral appliance treatment for obstructive sleep apnea: an update","volume":"10","author":"Sutherland","journal-title":"J Clin Sleep Med"},{"key":"R7","doi-asserted-by":"publisher","DOI":"10.1016\/j.smrv.2022.101644","article-title":"Comparison of the phenotypic characteristics between responders and non-responders to obstructive sleep apnea treatment using mandibular advancement devices in adult patients: systematic review and meta-analysis","volume":"64","author":"Cama\u00f1es-Gonzalvo","journal-title":"Sleep Med Rev"},{"issue":"Suppl 1","key":"R8","doi-asserted-by":"publisher","first-page":"S48","DOI":"10.21037\/jtd.2017.12.18","article-title":"An update on mandibular advancement devices for the treatment of obstructive sleep apnoea hypopnoea syndrome","volume":"10","author":"Basyuni","journal-title":"J Thorac Dis"},{"issue":"2","key":"R9","doi-asserted-by":"publisher","first-page":"135","DOI":"10.1093\/ejo\/23.2.135","article-title":"Orthodontic side-effects of mandibular advancement devices during treatment of snoring and sleep apnoea","volume":"23","author":"Marklund","journal-title":"Eur J Orthod"},{"issue":"5","key":"R10","doi-asserted-by":"publisher","first-page":"531","DOI":"10.1093\/sleep\/24.5.531","article-title":"Dental and skeletal changes associated with long-term mandibular advancement","volume":"24","author":"Robertson","journal-title":"Sleep"},{"issue":"2","key":"R11","doi-asserted-by":"publisher","first-page":"237","DOI":"10.1093\/sleep\/22.2.237","article-title":"Dental side effects of an oral device to treat snoring and obstructive sleep apnea","volume":"22","author":"Pantin","journal-title":"Sleep"},{"issue":"3","key":"R12","doi-asserted-by":"publisher","first-page":"131","DOI":"10.1007\/s11325-003-0131-7","article-title":"Effects of a mandibular protruding device on the sleep of patients with obstructive sleep apnea and snoring problems: a 2-year follow-up","volume":"7","author":"Fransson","journal-title":"Sleep Breath"},{"issue":"3","key":"R13","doi-asserted-by":"publisher","first-page":"137","DOI":"10.1177\/154411130401500303","article-title":"Efficacy and co-morbidity of oral appliances in the treatment of obstructive sleep apnea-hypopnea: a systematic review","volume":"15","author":"Hoekema","journal-title":"Crit Rev Oral Biol Med"},{"issue":"10","key":"R14","doi-asserted-by":"publisher","first-page":"962","DOI":"10.1164\/rccm.200806-981OC","article-title":"Effects of oropharyngeal exercises on patients with moderate obstructive sleep apnea syndrome","volume":"179","author":"Guimar\u00e3es","journal-title":"Am J Respir Crit Care Med"},{"key":"R15","unstructured":"Duarte-D\u00edaz A \u00c1lvarez-P\u00e9rez Y Santos-\u00c1lvarez A Toledo-Ch\u00e1varri A Valc\u00e1rcel-Nazco C Herrera-Ramos E et al. Terapia miofuncional (ejercicios orofar\u00edngeos) para la apnea obstructiva del sue\u00f1o [Report in Spanish]. Servicio de Evaluaci\u00f3n del Servicio Canario de la Salud (SESCS); 2024. URL: https:\/\/sescs.es\/terapia-miofuncional-apnea-obstructiva-sueno\/ [Accessed 03-12-2025]"},{"issue":"11","key":"R16","doi-asserted-by":"publisher","DOI":"10.2196\/23123","article-title":"Myofunctional therapy app for severe apnea-hypopnea sleep obstructive syndrome: pilot randomized controlled trial","volume":"8","author":"O\u2019Connor-Reina","journal-title":"JMIR Mhealth Uhealth"},{"issue":"2","key":"R17","doi-asserted-by":"publisher","first-page":"387","DOI":"10.1007\/s11325-016-1429-6","article-title":"Myofunctional therapy improves adherence to continuous positive airway pressure treatment","volume":"21","author":"Diaf\u00e9ria","journal-title":"Sleep Breath"},{"issue":"3","key":"R18","doi-asserted-by":"publisher","first-page":"725","DOI":"10.1002\/ohn.283","article-title":"Assessment of muscular weakness in severe sleep apnea patients: a prospective study","volume":"169","author":"O\u2019Connor-Reina","journal-title":"Otolaryngol Head Neck Surg"},{"key":"R19","unstructured":"Rodriguez\u2010Alcala L Ignacio JM . Effect of throat exercises in lower jaw advancement to treat sleep apnea. ISRCTN Registry. URL: https:\/\/www.isrctn.com\/ISRCTN13128082 [Accessed 08-12-2025]"},{"issue":"1","key":"R20","doi-asserted-by":"publisher","first-page":"63","DOI":"10.1007\/s11325-012-0647-9","article-title":"Does drug-induced sleep endoscopy change the treatment concept of patients with snoring and obstructive sleep apnea?","volume":"17","author":"Eichler","journal-title":"Sleep Breath"},{"issue":"Suppl 57","key":"R21","doi-asserted-by":"publisher","first-page":"4615","DOI":"10.1183\/13993003\/erj.42.Suppl_57.4615","article-title":"Drug-induced sleep endoscopy predictors for oral appliance treatment outcome","volume":"42","author":"Vroegop","journal-title":"Eur Respir J"},{"issue":"1","key":"R22","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1186\/s41606-019-0040-8","article-title":"New mHealth application software based on myofunctional therapy applied to sleep-disordered breathing in non-compliant subjects","volume":"4","author":"O\u2019Connor Reina","journal-title":"Sleep Science Practice"},{"issue":"6","key":"R23","doi-asserted-by":"publisher","DOI":"10.3390\/dj10060099","article-title":"Pilot study of a new mandibular advancement device","volume":"10","author":"Seg\u00f9","journal-title":"Dent J (Basel)"},{"issue":"11","key":"R24","doi-asserted-by":"publisher","first-page":"1230","DOI":"10.1016\/j.ijporl.2010.07.021","article-title":"Expanded protocol of orofacial myofunctional evaluation with scores: validity and reliability","volume":"74","author":"de Fel\u00edcio","journal-title":"Int J Pediatr Otorhinolaryngol"},{"issue":"11","key":"R25","doi-asserted-by":"publisher","DOI":"10.3390\/life12111841","article-title":"Evaluation of the muscle strength of the tongue with the tongue digital spoon (TDS) in patients with obstructive sleep apnea","volume":"12","author":"Rodr\u00edguez-Alcal\u00e1","journal-title":"Life (Basel)"},{"issue":"4","key":"R26","doi-asserted-by":"publisher","DOI":"10.1111\/jsr.13066","article-title":"On the rise and fall of the apnea-hypopnea index: a historical review and critical appraisal","volume":"29","author":"Pevernagie","journal-title":"J Sleep Res"},{"issue":"2","key":"R27","doi-asserted-by":"publisher","first-page":"175","DOI":"10.3758\/bf03193146","article-title":"G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences","volume":"39","author":"Faul","journal-title":"Behav Res Methods"},{"key":"R28","doi-asserted-by":"publisher","DOI":"10.1155\/2019\/4157898","article-title":"Floppy closing door epiglottis treated successfully with an mHealth application based on myofunctional therapy: a case report","volume":"2019","author":"O\u2019Connor Reina","journal-title":"Case Rep Otolaryngol"},{"issue":"24","key":"R29","doi-asserted-by":"publisher","DOI":"10.3390\/jcm10245772","article-title":"Improving adherence to myofunctional therapy in the treatment of sleep-disordered breathing","volume":"10","author":"O\u2019Connor-Reina","journal-title":"J Clin Med"},{"issue":"12","key":"R30","doi-asserted-by":"publisher","first-page":"1363","DOI":"10.1111\/joor.13247","article-title":"Sensorimotor tongue evaluation and rehabilitation in patients with sleep-disordered breathing: a novel approach","volume":"48","author":"Rodr\u00edguez-Alcal\u00e1","journal-title":"J Oral Rehabil"},{"issue":"8","key":"R31","doi-asserted-by":"publisher","DOI":"10.2196\/30500","article-title":"Muscular assessment in patients with severe obstructive sleep apnea syndrome: protocol for a case-control study","volume":"10","author":"Borrmann","journal-title":"JMIR Res Protoc"},{"issue":"4","key":"R32","doi-asserted-by":"publisher","first-page":"487","DOI":"10.5664\/jcsm.10900","article-title":"Evolution of adherence and self-reported symptoms over 36 months with mandibular advancement device therapy for obstructive sleep apnea: a retrospective study","volume":"20","author":"Sangalli","journal-title":"J Clin Sleep Med"}],"container-title":["JMIR Research Protocols"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.researchprotocols.org\/2025\/1\/e80521","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T18:14:02Z","timestamp":1782843242000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.researchprotocols.org\/2025\/1\/e80521"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,19]]},"references-count":32,"URL":"https:\/\/doi.org\/10.2196\/80521","relation":{},"ISSN":["1929-0748"],"issn-type":[{"value":"1929-0748","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,19]]},"article-number":"v14i8e80521"}}