Myofunctional Therapy App for Severe Apnea–Hypopnea Sleep Obstructive Syndrome: Pilot Randomized Controlled Trial

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