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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.
We conducted a pilot randomized trial to evaluate the effects of the app in patients with severe OSAHS.
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.
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 (
Orofacial exercises performed using an mHealth app reduced OSAHS severity and symptoms, and represent a promising treatment for OSAHS.
Spanish Registry of Clinical Studies AWGAPN-2019-01, ClinicalTrials.gov NCT04438785; https://clinicaltrials.gov/ct2/show/NCT04438785
Obstructive sleep apnea–hypopnea syndrome (OSAHS) is a serious health problem worldwide [
Patients with OSAHS present with impaired sensorimotor deficits located in the upper airway muscles [
Myofunctional therapy is one of the newest treatments for sleep-disordered breathing [
Most existing mobile health (mHealth) apps for OSAHS focus on the diagnosis of snoring or OSAHS [
Therefore, we conducted this pilot randomized trial to evaluate a new mHealth app based on proprioceptive training, which was designed to promote oropharyngeal exercises through interactions with a smartphone. In this prospective, randomized, multicenter clinical study, we evaluated adherence to the app and its effectiveness in a group of patients with severe OSAHS, as identified by an apnea–hypoxia index (AHI)>30 compared with a control group of similar patients who did not participate in the intervention.
The main objectives were to study the effects of the AirwayGym app on adherence to myofunctional therapy and on the AHI in patients recently diagnosed with severe OSAHS (AHI>30).
The secondary objectives were to evaluate the change in the oxygen desaturation index (ODI), use of the Iowa Oral Performance Instrument (IOPI) score to evaluate the effects of the app on the tone of the genioglossus and buccinator muscles, and use of the Epworth Sleepiness Scale and Pittsburgh Sleep Quality Index questionnaires to evaluate subjective morning somnolence and sleep quality.
This was a nonsponsored study coordinated by the Pulmonology and Otolaryngology Departments of Quirónsalud Marbella Hospital and Campo de Gibraltar Hospital, Andalucia, Spain. The protocol was designed and written by the authors and is available in
The CONSORT (Consolidated Standards of Reporting Trials) checklist [
This was a prospective controlled quasiexperimental clinical study in patients with severe OSAHS (AHI>30).
Patients newly diagnosed with severe OSAHS based on the results of polysomnography or respiratory polygraphy with measures of AHI and oxygen saturation were recruited offline in a clinical setting. All sleep studies were interpreted manually by a sleep technician according to the standard criteria of the American Academy of Sleep Medicine Manual for the Scoring of Sleep and Associated Events [
Information about the inclusion and exclusion criteria, evaluation of the type of smartphone used, previous experience with the app, and the study protocol are provided in
All patients agreed to participate and provided offline informed consent. At the initial visit, participants were evaluated by an otorhinolaryngologist who performed rhinofibrolaryngoscopy, Friedman staging, the Marchesani protocol [
Randomization was based on the consecutive order of patient enrollment. A pulmonologist specialist allocated odd-numbered patients to the AirwayGym app group and even-numbered patients to the control group.
Participants in the AirwayGym group were instructed about the use of the app and the exercises to perform for 20 minutes daily. Follow-up visits for both the AirwayGym and control groups occurred after 1 month (visit 3) and 3 months (visit 4). At these visits, all variables were measured again and the questionnaires were completed, and the patients were asked whether they were using any other therapies. In the final visit at 3 months, polysomnography or polygraphy was performed for both groups. The total study duration for each participant was 3 months.
Participants were excluded from the study if they were lost to follow up because they did not attend hospital visits or if they lost ≥5% of body weight during the study. Patients in the AirwayGym group were also excluded if they did not perform ≤85% of the scheduled exercise sessions, as monitored by the app.
Participants in the AirwayGym group committed to using the AirwayGym app. This app was created as a collaboration between the sleep units of Quirónsalud Marbella Hospital and Campo de Gibraltar Hospital. The app can be thought of as a portable fitness app except that the user is intended for patients rather than athletes, and therapists rather than trainers provide the instructions. The novelty of this app is that it is the first app in the health care market that allows the patient to interact directly with the smartphone without needing any other device. The app focuses on sleep apnea disease and improving proprioceptive deficits. When used with the app, the phone provides acoustic feedback about the efficacy of the exercises performed.
The app includes 9 exercises based on myofunctional therapy (
The main objective of the exercises in the app is to increase the tone of the extrinsic muscles of the tongue (genioglossus, hyoglossus, styloglossus, and palatoglossus). The exercises are based on those described elsewhere [
Screenshot of a gif showing an exercise.
Screenshot of a patient’s progress in following the exercises for 1 year.
Standard laboratory polysomnography (Somté PSG, Compumedics Ltd 2006, Abbotsford, Australia) was performed according to the technical specifications of the American Academy of Sleep Medicine [
Respiratory polygraphy was performed using an Embletta portable diagnostic system (ResMed, Sydney, Australia) according to the technical specifications of the American Academy of Sleep Medicine [
All patients were evaluated using the same testing procedure (polysomnography or respiratory polygraphy) before and after the intervention. The results for each participant were analyzed manually by a technician who was blinded to the participant’s assigned group.
The pulmonologist’s medical evaluation was used to determine which test was chosen for each patient. Apnea and hypopnea were analyzed and scored according to the following criteria. Hypopnea was defined as a ≥30% decrease in airflow signal amplitude lasting ≥10 seconds and accompanied by ≥3% oxygen desaturation. Apnea was defined as a ≥90% decrease in airflow signal amplitude lasting ≥10 seconds. The ODI was used to quantify oxygen desaturation ≥3% Both tests were used to define moderate OSAHS as an AHI of 15-29.9 events/hour of sleep and severe OSA as ≥30 events/hour of sleep.
Detailed information about this device and measurements is provided in
The effectiveness of use of the app for performing myofunctional therapy in patients with severe OSAHS was evaluated using the percentage changes in the AHI observed during follow up as the primary outcome measure. This percentage was calculated from results reported in previous studies of myofunctional therapy [
Data were collected in a database. Nominal variables are described by their frequency distribution. Quantitative variables were assessed by calculating the median and IQR. Baseline characteristics of the 2 groups of patients with OSAHS were compared using two-tailed paired
Of the 60 patients initially recruited, 40 patients were enrolled and randomized from February 2019 to July 2020. Twenty of the 60 patients were excluded, 10 (17%) because of the exclusion criteria and 10 (17%) because of findings in the otorhinolaryngologist’s examination. Six of the 40 patients were excluded because of a change in body weight, 4 voluntarily abandoned the study in the control group, and 2 patients were lost because of poor adherence to therapy in the AirwayGym group. Finally, the data for 28 patients (22 men) were included in the study (
The baseline demographic and sleep characteristics are presented for the two groups in
CONSORT flowchart for pilot randomized trials for recruitment of participants in this study. AGG: AirwayGym group; CG: control group.
Baseline characteristics of the study participants.
Characteristic | Control (n=10) | AirwayGym (n=18) | ||
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Age (years), median (IQR) | 63.9 (56.4-71.38) | 59.17 (53.7-64.6) | .19 |
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Female, n (%) | 2 (20) | 4 (22) | .95 |
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Body weight (kg), median (IQR) | 87.7 (77.9-97.4) | 86.11 (77.4-94.8) | .86 |
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Height (cm), median (IQR) | 170.2 (166.2-174.1) | 177.1 (166.3-177.9) | .52 |
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Waist circumference (cm), median (IQR) | 109.1 (97.5-120.6) | 109.2 (102.9-115.4) | .98 |
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Neck circumference (cm), median (IQR) | 43.7 (40.3-47) | 43.74 (41.03-46.4) | .99 |
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BMI (kg/m2), median (IQR) | 29.6 (27.1-32.08) | 28.9 (26.8-31.02) | .67 |
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Friedman stage, n (stage) | 2 (I), 3 (II), 2 (III), 3 (IV) | 4 (I), 4 (II), 3 (III), 7 (IV) | .95 |
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AHIa/hour, median (IQR) | 47.36 (38.59-56.13) | 44.77 (33.841-55.69) | .70 |
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ODIb, median (IQR) | 40.6 (29.46-51.81) | 36.31 (27.1-43.43) | .54 |
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IOPIc max tongued, median (IQR) | 42 (32.67-51.33) | 40.26 (35.32-45.2) | .70 |
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IOPI max lipse, median (IQR) | 28.10 (23.7-32.5) | 28.3 (24.16-32.47) | .94 |
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Pittsburgh Sleep Quality Index, median (IQR) | 8.80 (7.12-10.48) | 10.1 (8.22-11.99) | .34 |
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Epworth Sleepiness Scale, median (IQR) | 9.3 (6.6-12) | 10.47 (8.71-12.24) | .42 |
aAHI: apnea–hypopnea index.
bODI: oxygen desaturation index.
cIOPI: Iowa Oral Performance Instrument.
dmaximum tongue elevation strength.
emaximum lip strength.
After the intervention period, none of the variables changed significantly in the control group (
Changes in variables from the baseline to 3-month follow up in the control and AirwayGym groups.
Variable | Control group (n=10) | AirwayGym group (n=18) | |||||
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Baseline, median (IQR) | After 3 months, median (IQR) | Baseline, median (IQR) | After 3 months, median (IQR) | |||
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Body weight (kg) | 87.7 (77.9-97.4) | 87.3 (78.03-95.66) | .95 | 86.1 (77.4-94.8) | 86.00 (77.93-94.06) | .92 |
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Height (cm) | 170.2 (166.2-174.1) | 169.80 (166.27-174.12) | .98 | 177.1 (166.3-177.9) | 172.6 (167.3-177.9) | 1.00 |
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Waist circumference (cm) | 109.1 (97.5-120.6) | 108.5 (96.9-120.10) | .94 | 109.2 (102.9-115.4) | 108.84 (102.7-114.9 | .92 |
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Neck circumference (cm) | 43.7 (40.3-47) | 43.5 (40.33-46.67) | .92 | 43.74 (41.03-46.4) | 44.6 (42.12-47.2) | .60 |
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BMI (kg/m2) | 29.63 (27.1-32.08) | 29.6 (27.35-31.84) | .94 | 28.9 (26.8-31.02) | 28.81 (26.79-30.83) | .92 |
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AHIa (events/hour) | 47.36 (38.59-56.13) | 35.00 (31.2-38.7) | .07 | 44.77 (33.84-55.69) | 20.88 (14.02-27.74) | <.001 |
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ODIb | 40.64 (29.46-51.81) | 32.03 (24.14-39.91) | .17 | 36.31 (27.19-43.43) | 19.4 (12.9-25.98) | .003 |
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IOPIc max tongued | 42 (32.67-51.33) | 44.2 (34.1-54.2) | .72 | 39.83 (35.32-45.2) | 59.06 (54.74-64.00) | <.001 |
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IOPI max lipse | 28.10 (23.7-32.5) | 31.3 (26.6-35.9) | .27 | 27.89 (24.16-32.47) | 44.11 (39.5-48.8) | <.001 |
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Pittsburgh Sleep Quality Index | 8.80 (7.12-10.48) | 9.78 (7.2-12.11) | .50 | 10.2 (8.22-11.99) | 8.28 (5.97-10.35) | .22 |
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Epworth Sleepiness Scale | 9.3 (6.6-12.0) | 9.6 (6.8-12.3) | .86 | 10.33 (8.71-12.24) | 5.37 (3.45-7.28) | <.001 |
aAHI: apnea–hypopnea index.
bODI: oxygen desaturation index.
cIOPI: Iowa Oral Performance Instrument.
dmaximum tongue elevation strength.
emaximum lip strength.
The anthropometric measures did not change significantly in the intervention group (
The AHI decreased by 53.36% from 44.7 (IQR 33.8-55.6) to 20.88 (IQR 14.02-27.7) events/hour (
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.
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.
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.
The Epworth Sleepiness Scale score decreased from 10.33 (IQR 8.71-12.24) to 5.37 (IQR 3.45-7.28) (
This prospective study showed that an mHealth app that includes education about myofunctional therapy exercises for patients with severe OSAHS helped to improve the AHI and upper airway muscle tone. This is the first report in the literature to show significant correlations between the increase in tone, as measured by the IOPI, and improvements in the AHI in patients with severe OSAHS.
The main criticisms of previous reports on the use of myofunctional therapy to treat OSAHS patients are that the myofunctional therapy included different kinds of exercises and the authors did not explain the reason for improvement [
Eckert [
We believe that the reason for the success of this app in patients with severe OSAHS is that myofunctional therapy must be based on proprioceptive training because of the sensorimotor deficit in the upper airway muscles in these patients [
The main disadvantages of myofunctional therapy are the poor adherence to therapy [
Instead of using placebo exercises, as employed in other studies [
The selection of patients suitable for myofunctional therapy is important [
Although further evidence of the efficacy of this app is needed, we consider that this therapy will help to improve adherence to other treatments, as has been suggested previously [
Despite the strengths of this pilot study mentioned above, we note several limitations. First, the number of participants was small. Second, we found a significant loss of participants in the control group (50%), who were instructed not to perform any therapy once they had been diagnosed with severe OSAHS. Despite this loss, our sample size was similar to that included in other clinical studies of this therapy [
In patients with OSAHS who performed myofunctional therapy exercises using this app, the severity of symptoms decreased and the tone of the upper airway muscles increased after 3 months. This app may represent a promising treatment for OSAHS given its convenience and availability of the mobile phone market.
Study protocol.
CONSORT checklist.
Screenshots from the app.
Video of exercise 1: chromatic snake.
Video of exercise 2: Snake.
Video of exercise 3: Chameleon up.
Video of exercise 4: Chameleon down.
Video of exercise 5: Tongue left cheek.
Video of exercise 6: Tongue right cheek.
Video of exercise 7: Pressure under the chin.
Video of exercise 8: Left mandibular pressure.
Video of exercise 9: Right mandibular pressure.
apnea–hypoxia index
Consolidated Standards of Reporting Trials
continuous positive airway pressure
Iowa Oral Performance Instrument
mobile health
oxygen desaturation index
obstructive sleep apnea–hypopnea syndrome
upper airway stimulation device
CR is the creator of, and has financial interest in, the AirwayGym app. All other authors declare no conflict of interest.