%0 Journal Article %@ 2291-5222 %I JMIR Publications %V 8 %N 11 %P e23123 %T Myofunctional Therapy App for Severe Apnea–Hypopnea Sleep Obstructive Syndrome: Pilot Randomized Controlled Trial %A O'Connor-Reina,Carlos %A Ignacio Garcia,Jose Maria %A Rodriguez Ruiz,Elisa %A Morillo Dominguez,Maria Del Carmen %A Ignacio Barrios,Victoria %A Baptista Jardin,Peter %A Casado Morente,Juan Carlos %A Garcia Iriarte,Maria Teresa %A Plaza,Guillermo %+ Otorhinolaryngology Department, Hospital Quironsalud Marbella, Avda Severo Ochoa 22, Marbella, Spain, 34 952774200, carlos.oconnor@quironsalud.es %K myofunctional therapy %K oropharyngeal exercises %K mHealth %K sleep apnea %K smartphone app %K app %K sleep %K therapy %K apnea %K randomized trial %K efficacy %D 2020 %7 9.11.2020 %9 Original Paper %J JMIR Mhealth Uhealth %G English %X Background: Myofunctional therapy has demonstrated efficacy in treating sleep-disordered breathing. We assessed the clinical use of a new mobile health (mHealth) app that uses a smartphone to teach patients with severe obstructive sleep apnea–hypopnea syndrome (OSAHS) to perform oropharyngeal exercises. Objective: We conducted a pilot randomized trial to evaluate the effects of the app in patients with severe OSAHS. Methods: Forty patients with severe OSAHS (apnea–hypoxia index [AHI]>30) were enrolled prospectively and randomized into an intervention group that used the app for 90 sessions or a control group. Anthropometric measures, Epworth Sleepiness Scale (0-24), Pittsburgh Sleep Quality Index (0-21), Iowa Oral Performance Instrument (IOPI) scores, and oxygen desaturation index were measured before and after the intervention. Results: After the intervention, 28 patients remained. No significant changes were observed in the control group; however, the intervention group showed significant improvements in most metrics. AHI decreased by 53.4% from 44.7 (range 33.8-55.6) to 20.88 (14.02-27.7) events/hour (P<.001). The oxygen desaturation index decreased by 46.5% from 36.31 (27.19-43.43) to 19.4 (12.9-25.98) events/hour (P=.003). The IOPI maximum tongue score increased from 39.83 (35.32-45.2) to 59.06 (54.74-64.00) kPa (P<.001), and the IOPI maximum lip score increased from 27.89 (24.16-32.47) to 44.11 (39.5-48.8) kPa (P<.001). The AHI correlated significantly with IOPI tongue and lip improvements (Pearson correlation coefficient −0.56 and −0.46, respectively; both P<.001). The Epworth Sleepiness Scale score decreased from 10.33 (8.71-12.24) to 5.37 (3.45-7.28) in the app group (P<.001), but the Pittsburgh Sleep Quality Index did not change significantly. Conclusions: Orofacial exercises performed using an mHealth app reduced OSAHS severity and symptoms, and represent a promising treatment for OSAHS. Trial Registration: Spanish Registry of Clinical Studies AWGAPN-2019-01, ClinicalTrials.gov NCT04438785; https://clinicaltrials.gov/ct2/show/NCT04438785 %M 33093013 %R 10.2196/23123 %U http://mhealth.jmir.org/2020/11/e23123/ %U https://doi.org/10.2196/23123 %U http://www.ncbi.nlm.nih.gov/pubmed/33093013