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Randomized Controlled Trial
. 2020 Nov 9;8(11):e23123.
doi: 10.2196/23123.

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

Affiliations
Randomized Controlled Trial

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

Carlos O'Connor-Reina et al. JMIR Mhealth Uhealth. .

Abstract

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.

Keywords: apnea; app; efficacy; mHealth; myofunctional therapy; oropharyngeal exercises; randomized trial; sleep; sleep apnea; smartphone app; therapy.

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Conflict of interest statement

Conflicts of Interest: CR is the creator of, and has financial interest in, the AirwayGym app. All other authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Screenshot of a gif showing an exercise.
Figure 2
Figure 2
Screenshot of a patient’s progress in following the exercises for 1 year.
Figure 3
Figure 3
CONSORT flowchart for pilot randomized trials for recruitment of participants in this study. AGG: AirwayGym group; CG: control group.
Figure 4
Figure 4
Apnea–hypopnea index (AHI) before (baseline) and after 3 months in patients with severe obstructive sleep apnea. Intragroup comparison from before to after the study was performed using the Wilcoxon test owing to the skewed data distribution. CG: control group; AGG: AirwayGym group.
Figure 5
Figure 5
Iowa Oral Performance Instrument (IOPI) tongue strength (kPa) at baseline and after 3 months in patients with severe obstructive sleep apnea. The intragroup comparison is shown from before to after the study. AGG: AirwayGym group; CG: control group.
Figure 6
Figure 6
Iowa Oral Performance Instrument (IOPI) lip strength (kPa) at baseline and after 3 months in patients with severe obstructive sleep apnea. The intragroup comparison is shown from before to after the study. AGG: AirwayGym group; CG: control group.

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