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

Myofunctional therapy (MT) is used to treat sleep-disordered breathing. However, MT has low adherence—only ~10% in most studies. We describe our experiences with MT delivered through a mobile health app named Airway Gym®, which is used by patients who have rejected continuous positive airway pressure and other therapies. We compared ear, nose, and throat examination findings, Friedman stage, tongue-tie presence, tongue strength measured using the Iowa oral performance instrument (IOPI), and full polysomnography before and after the 3 months of therapy. Participants were taught how to perform the exercises using the app at the start. Telemedicine allowed physicians to record adherence to and accuracy of the exercise performance. Fifty-four patients were enrolled; 35 (64.8%) were adherent and performed exercises for 15 min/day on five days/week. We found significant changes (p < 0.05) in the apnoea–hypopnoea index (AHI; 32.97 ± 1.8 to 21.9 ± 14.5 events/h); IOPI score (44.4 ± 11.08 to 49.66 ± 10.2); and minimum O2 saturation (80.91% ± 6.1% to 85.09% ± 5.3%). IOPI scores correlated significantly with AHI after the therapy (Pearson r = 0.4; p = 0.01). The 19 patients who did not adhere to the protocol showed no changes. MT based on telemedicine had good adherence, and its effect on AHI correlated with IOPI and improvement in tongue-tie.

Background Myofunctional therapy is currently a reasonable therapeutic option to treat obstructive sleep apnea-hypopnea syndrome (OSAHS). This therapy is based on performing regular exercises of the upper airway muscles to increase their tone and prevent their collapse. Over the past decade, there has been an increasing number of publications in this area; however, to our knowledge, there are no studies focused on patients who can most benefit from this therapy. Objective This protocol describes a case-control clinical trial aimed at determining the muscular features of patients recently diagnosed with severe OSAHS compared with those of healthy controls. Methods Patients meeting set criteria will be sequentially enrolled up to a sample size of 40. Twenty patients who meet the inclusion criteria for controls will also be evaluated. Patients will be examined by a qualified phonoaudiologist who will take biometric measurements and administer the Expanded Protocol of Orofacial Myofunctional Evaluation with Scores (OMES), Friedman Staging System, Epworth Sleepiness Scale, and Pittsburgh Sleep Quality Index questionnaires. Measures of upper airway muscle tone will also be performed using the Iowa Oral Performance Instrument and tongue digital spoon devices. Evaluation will be recorded and reevaluated by a second specialist to determine concordance between observers. Results A total of 60 patients will be enrolled. Both the group with severe OSAHS (40 patients) and the control group (20 subjects) will be assessed for differences between upper airway muscle tone and OMES questionnaire responses. Conclusions This study will help to determine muscle patterns in patients with severe OSAHS and can be used to fill the gap currently present in the assessment of patients suitable to be treated with myofunctional therapy. Trial Registration ISRCTN Registry ISRCTN12596010; https://www.isrctn.com/ISRCTN12596010 International Registered Report Identifier (IRRID) PRR1-10.2196/30500

BACKGROUND Myofunctional therapy is currently a reasonable therapeutic option to treat obstructive sleep apnea-hypopnea syndrome (OSAHS). This therapy is based on performing regular exercises of the upper airway muscles to increase their tone and prevent their collapse. Over the past decade, there has been an increasing number of publications in this area; however, to our knowledge, there are no studies focused on patients who can most benefit from this therapy. OBJECTIVE This protocol describes a case-control clinical trial aimed at determining the muscular features of patients recently diagnosed with severe OSAHS compared with those of healthy controls. METHODS Patients meeting set criteria will be sequentially enrolled up to a sample size of 40. Twenty patients who meet the inclusion criteria for controls will also be evaluated. Patients will be examined by a qualified phonoaudiologist who will take biometric measurements and administer the Expanded Protocol of Orofacial Myofunctional Evaluation with Scores (OMES), Friedman Staging System, Epworth Sleepiness Scale, and Pittsburgh Sleep Quality Index questionnaires. Measures of upper airway muscle tone will also be performed using the Iowa Oral Performance Instrument and tongue digital spoon devices. Evaluation will be recorded and reevaluated by a second specialist to determine concordance between observers. RESULTS A total of 60 patients will be enrolled. Both the group with severe OSAHS (40 patients) and the control group (20 subjects) will be assessed for differences between upper airway muscle tone and OMES questionnaire responses. CONCLUSIONS This study will help to determine muscle patterns in patients with severe OSAHS and can be used to fill the gap currently present in the assessment of patients suitable to be treated with myofunctional therapy. CLINICALTRIAL ISRCTN Registry ISRCTN12596010; https://www.isrctn.com/ISRCTN12596010 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/30500

BACKGROUND Rationale: Myofunctional therapy has demonstrated efficacy for treating sleep-disordered breathing. We assessed the clinical use of a new mobile health (mHealth) app that teaches patients with severe obstructive sleep apnea–hypopnea syndrome (OSAHS) to perform oropharyngeal exercises using their smartphone. OBJECTIVE To examine 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, O2 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 53.36% from 44.7 (33.8–55.6) to 20.88 (14.02–27.7) events/h (P < 0.00001). Oxygen desaturation index decreased 46.5% from 36.31 (27.19–43.43) to 19.4 (12.9–25.98) events/h (P = 0.003). IOPI maximum tongue score increased from 39.83 (35.32–45.20) to 59.06 (54.74–64.00) kPa (P = 0.0001). IOPI maximum lip score increased from 27.89 (24.16–32.47) to 44.11 (39.5–48.80) kPa (P = 0.0003). The AHI correlated significantly with IOPI tongue and lip improvements (Pearson –0.560, P = 0.00001 and –0.460, P = 0.0001, respectively). CONCLUSIONS Orofacial exercises performed using an mHealth app reduce OSAHS severity and symptoms, and represent a promising treatment for OSAHS. CLINICALTRIAL Spanish Gov identifier: AWGAPN-2019-01 ClinicalTrials.gov Identifier: NCT04438785