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

BACKGROUND 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), and Iowa Oral Performance Instrument (IOPI) scores, and oxygen desaturation index were obtained before and after the intervention. RESULTS After the intervention, 28 patients remained. No significant changes were observed in the control group. The intervention group showed significant improvements. AHI decreased 53.4% from 44.7 (range 33.8-55.6) to 20.88 (14.02-27.7) events/h (P<.001). Oxygen desaturation index decreased 46.5% from 36.31 (27.19-43.43) to 19.4 (12.9-25.98) events/h (P=.003). IOPI maximum tongue score increased from 39.83 (35.32-45.2) to 59.06 (54.74-64.00) kPa (P<.001). 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 coefficient -0.56, P<.001, and -0.46, P<.001, respectively). The Epworth Sleepiness Scale score decreased from 10.33 (8.71-12.24) to 5.37 (3.45-7.28) (P<.001) in the app group, but the Pittsburgh Sleep Quality Index did not change significantly. CONCLUSIONS Orofacial exercises performed using an mHealth app reduce OSAHS severity and symptoms, and represent a promising treatment for OSAHS. CLINICALTRIAL Spanish Gov AWGAPN-2019-01; ClinicalTrials.gov NCT04438785.