TY - JOUR AU - O'Connor-Reina, Carlos AU - Ignacio Garcia, Jose Maria AU - Rodriguez Ruiz, Elisa AU - Morillo Dominguez, Maria Del Carmen AU - Ignacio Barrios, Victoria AU - Baptista Jardin, Peter AU - Casado Morente, Juan Carlos AU - Garcia Iriarte, Maria Teresa AU - Plaza, Guillermo PY - 2020 DA - 2020/11/9 TI - Myofunctional Therapy App for Severe Apnea–Hypopnea Sleep Obstructive Syndrome: Pilot Randomized Controlled Trial JO - JMIR Mhealth Uhealth SP - e23123 VL - 8 IS - 11 KW - myofunctional therapy KW - oropharyngeal exercises KW - mHealth KW - sleep apnea KW - smartphone app KW - app KW - sleep KW - therapy KW - apnea KW - randomized trial KW - efficacy AB - 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 SN - 2291-5222 UR - http://mhealth.jmir.org/2020/11/e23123/ UR - https://doi.org/10.2196/23123 UR - http://www.ncbi.nlm.nih.gov/pubmed/33093013 DO - 10.2196/23123 ID - info:doi/10.2196/23123 ER -