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Myofunctional therapy app for severe apnea-hypopnea sleep obstructive syndrome: a pilot randomized controlled trial
O'Connor-Reina C, Ignacio-Garcia JM, Rodriguez-Ruiz E, Morillo Dominguez MDC, Ignacio Barrios V, Baptista Jardin P, Casado Morente JC, Garcia Iriarte MT, Plaza G
JMIR MHealth and UHealth 2020 Nov;8(11):e23123
clinical trial
4/10 [Eligibility criteria: Yes; Random allocation: No; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: No; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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 to 24), Pittsburgh Sleep Quality Index (0 to 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 to 55.6) to 20.88 (14.02 to 27.7) events/h (p < 0.001). Oxygen desaturation index decreased 46.5% from 36.31 (27.19 to 43.43) to 19.4 (12.9 to 25.98) events/h (p = 0.003). IOPI maximum tongue score increased from 39.83 (35.32 to 45.2) to 59.06 (54.74 to 64.00) kPa (p < 0.001). IOPI maximum lip score increased from 27.89 (24.16 to 32.47) to 44.11 (39.5 to 48.8) kPa (p < 0.001). The AHI correlated significantly with IOPI tongue and lip improvements (Pearson coefficient -0.56, p < 0.001, and -0.46, p < 0.001, respectively). The Epworth Sleepiness Scale score decreased from 10.33 (8.71 to 12.24) to 5.37 (3.45 to 7.28) (p < 0.001) 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. CLINICAL TRIAL: Spanish Gov AWGAPN-2019-01; ClinicalTrials.gov NCT04438785.

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