Effects of Myofunctional Therapy With an M-health Application Airway Gym in Severe Apnea/Hypopnea Sleep Obstructive Syndrome: A Randomized Multicentre Control Trial
Phase: NA
Conditions: Obstructive Sleep Apnea-hypopnea Syndrome
Sponsor: Quironsalud

 
Myofunctional Therapy App for Severe Apnea–Hypopnea Sleep 
Obstructive Syndrome: A Randomized  Trial 
Spanish Gov identifier: AWGAPN-2019-01 
 
 
ClinicalTrials.gov Identifier: NCT04438785 
 
February 1st 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
Introduction 
Obstructive sleep apnea/hypopnea syndrome (OSAHS) has become one of the most 
serious health problems worldwide (1). Because of its association with obesity, the 
prevalence and incidence of OSAHS have been increasing, and the condition is 
associated with morbidities such as cardiovascular and cerebrovascular diseases. The 
classic treatment of this disease is based on dietary measures, weight loss, exercise, and 
use of a continuous positive airway pressure (CPAP) machine, a device that reduces the 
collapsibility of the upper airway by emitting a flow of air. Other options are upper 
airway surgery to treat obstacles in the airway or to correct the muscles that do not 
perform their function properly, and mandibular advancement devices (MADs), which 
protrude the tongue forward to prevent it falling backward and collapsing the airway. 
The success rates for such procedures are variable, and the indications and level of 
success depend on the severity of the disease and patient adherence to the treatment (1). 
Myofunctional therapy (MT) is one of the newest treatments for sleep-disordered 
breathing (2). MT is based on daily exercises using the oropharyngeal muscles that aim 
to strengthen the muscles and to facilitate opening of the airway. OSAHS originates 
from the lack of optimal function of the dilator muscles of the airway, and MT is 
designed, theoretically, to correct the underlying mechanisms causing this disease (3). 
MT includes oropharyngeal exercises, which are described using diagrams, videos, and 
instructions provided by a myofunctional therapist on a weekly basis. The patient is 
instructed to perform the exercises regularly for 20 to 40 min daily for at least 3 months. 
In some cases, the patients perform the exercises by themselves at home without 

 
substantial feedback and without providing precise information to the therapist about 
their performance of the exercises (4). 
Most existing mobile health (mHealth) applications (apps) for patients with 
OSAHS focus on the diagnosis of snoring or OSAHS (5), although a few are designed 
to promote adherence to treatment with CPAP (6). To our knowledge, none of these 
apps focus on the treatment of OSAHS. However, mobile technology may be valuable 
in treating OSAHS patients because of its potential to promote patient empowerment 
and self-management (7). 
Exercise and weight loss are two of the best treatments for OSAHS (7, 8). Given 
time limitations, we consider that patients are more likely to perform exercises if they 
are able to do so while sitting comfortably and watching television. Therefore, we 
designed and developed a novel mHealth app to teach and promote the use of 
oropharyngeal exercises using a smartphone. In this prospective, randomized, 
multicenter clinical trial, we will assess adherence to the use of the app and its 
effectiveness in a group of patients with severe OSAHS compared with a control group. 
Hypothesis 
Regular use of the AirwayGym app, which is designed to help patients perform MT, 
will increase adherence to MT and improve symptoms in patients with severe disease 
OSAHS (apnea–hypoxia index (AHI) > 30) by increasing the tone of the upper airway 
muscles. 
Objectives 
Primary Objective 
The main objective is to study the evolution of the efficacy of the AirwayGym app for 
performing MT in patients diagnosed with severe OSAHS. 

 
Secondary Objectives 
The secondary objectives are as follows. 
1. To evaluate the effects of MT used via the app on the AHI in patients diagnosed with 
severe OSAHS. 
2. To evaluate the effects of the app on the O2 desaturation index in these patients. 
3. To evaluate the effects of the app on the tone of the genioglossus and buccinator 
muscles as assessed using the Iowa Oral Performance Instrument (IOPI). 
4. To evaluate subjective ratings of morning somnolence and sleep quality as assessed 
using the Epworth Sleepiness Score and Pittsburgh Sleep Quality Index. 
Methods 
Design 
This will be a prospective, controlled, quasi-experimental clinical trial in patients with 
severe OSAHS (AHI > 30). 
Place 
Patients recently diagnosed  for severe OSAHA in the neumology unit of Hospital 
Quirónsalud Marbella and Hospital Campo de Gibraltar will be recruited. 
Population 
Patients recently diagnosed with severe sleep apnea and accepted to participate in this 
clinical trial. 
Inclusion Criteria 
✓ age 18–75 years 
✓ recently diagnosed with severe sleep apnea but with no previous experience with 
this pathology 
✓ provision of informed written consent. 

 
Exclusion Criteria 
✓ BMI> 40 
✓ inability to complete the questionnaires 
✓ severe drug or alcohol abuse 
✓ use of hypnotic medication 
✓ uncontrolled coronary disease 
✓ decompensated heart failure 
✓ history of stroke 
✓ systemic disease associated with an inflammatory-related entity (e.g., arthritis, 
sarcoidosis, vasculitis, lupus) 
✓ neuromuscular disease (e.g., Duchenne muscular dystrophy) 
✓ craniofacial deformity 
✓ active oncology 
✓ any previous use of MT treatment or other treatments for sleep apnea that could 
affect the study results (e.g., surgery, MAD, or CPAP). 
After the patient is accepted into the study and signs the informed consent form, the 
patient will be examined by an ear, nose, and throat (ENT) specialist to rule out the 
following conditions. 
1. severe upper airway obstruction (complete nose obstruction, tonsils grade III/IV) 
2. presence of tongue-tie (Marchesani protocol) (9) that limits tongue movements 
3. antecedents or presence of temporomandibular joint disorder. 
Patients with any of these features will be excluded from the study even after initial 
acceptance. 

 
Sample Size Calculation and Sampling Procedure 
Evaluation of the effectiveness of the app for MT in patients with severe OSAHS will 
be based on the percentage changes in the AHI observed during the follow-up in the 
longitudinal study  . This percentage has been calculated using results reported in 
previous MT studies (10) . With a statistical confidence level of 95%, power of 80%, 
and estimated improvement of the AHI of 60%, we have calculated that a sample size of 
30 patients will be needed (15 in the intervention group, 15 in the control group). To 
compensate for the potential loss during the inclusion process (including patients with 
selection bias), early withdrawal, or loss during follow-up, we will increase the sample 
size by 100% to 60. Sample size was calculated using XLSTAT (v16 ,Addinsof).   
Patients will be randomized in consecutive order of enrollment, with odd-
numbered patients allocated to the intervention group and even-numbered patients to the 
control group. Patients without a smartphone will be assigned directly to the control 
group. 
Parameters of Interest 
Age, sex, weight, height, BMI, waist circumference (at the umbilicus), neck 
circumference, IOPI tonge  and lip cores, AHI, O2 desaturation index, and Friedman 
tongue stage will be assessed. Patients will complete the Epworth Sleepiness Score and 
Pittsburgh Sleep Quality Index questionnaires. 
Development and Use of the App 
The intervention group will use the mHealth AirwayGym app. 
This app is a smartphone app created in a collaboration between the Sleep Units 
of Hospital Quirónsalud Marbella and Hospital Campo de Gibraltar and their 

 
Engineering Informatics Departments and developed by Apnea Bye. It was developed 
last November 2018. 
We think of this app as a portable fitness app, except that patients and not athletes 
use the app, and therapists instead of trainers provide the instruction. The novelty of this 
app is that it is the first in the health-care market in which the patient can interact 
directly with the smartphone without any other device. The app focuses on sleep apnea 
disease and improving proprioceptive deficits. The app includes nine exercises based on 
MT aimed at improving the tonicity of the various muscles involved in the pathogenesis 
of OSAHS. Before every exercise, an animated demonstration and a video show the 
patient how to perform the exercise (Fig. E1–3). The user can follow the progress of 
their activity daily over time (Fig. E4–6). After each exercise, the patient receives 
feedback about the success of their performance as a point score (Fig. E 7). When the 
patient finishes the exercises, the results are saved on networked online storage (in the 
cloud), and a therapist can evaluate the patient’s performance of the exercises (Fig. E 8). 
A chat function is available through which the patient can contact the therapist directly. 
Therapists can also use the app to enroll and follow up on their patients. 
The app sends a reminder every 5 days if the patient “forgets” to perform the 
exercises. An English-language version of this app is now available; the Android app is 
available via Google Play and the iOS version via the App Store. Full information about 
the app is provided at https://airwaygym.App/. 
This app was developed using the most cutting-edge technologies (e.g., Ionic, 
Angular provided by Google and TypeScript by Microsoft) and the most consolidated 
software languages (e.g., HTML5, CSS3, and PHP). The app takes advantage of 3D 
Touch technology, which accurately measures the pressure applied to the mobile screen 

 
and is available in the latest Apple devices. This app complies with regulation 2002/58/ 
CE and (UE) 2016/679 about data protection. 
Exercises using the App 
The main objective of the exercises included 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 by Guimaraes in 2009 (8) 
and have been adapted to obtain feedback using the app. For reasons related to hygiene, 
we recommend that users cover the screen with cling film or a hypoallergenic plastic 
wrap when performing the exercises. See description and videos 1-9 
 
Patients in the control group will not be given any therapy for OSAHS for 3 
months. 
All patients will visit their hospital once a month for measurement of variables 
(weight, height, BMI, neck and waist circumferences), and to complete the 
questionnaires.  
Hospital Visits 
Selection Visit 
Patients newly diagnosed with severe OSAHS based on the results of laboratory 
polysomnography or polygraphy with measures of AIH and O2 desaturation index will 
be recruited. All sleep studies will be 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 and will be reviewed by certified 
physicians. Patients will be evaluated against the inclusion and exclusion criteria, and 
their type of mobile phone and their previous experience with apps will be recorded. 

 
Information about the study will be provided to the participants, who will then have the 
opportunity to ask questions and have their doubts resolved. Patients accepted into the 
study will then sign the informed consent form. 
Initial Visit 
During the initial visit, the patient will be evaluated by an ENT specialist, who will use 
oropharyngoscopy, rhinofibrolaryngoscopy, and the Marchesani protocol to examine 
the patient and to assess the Friedman stage and temporomandibular joint dysfunction. 
Patients with tonsil grade IV, complete nose obstruction, ankyloglossia, or 
temporomandibular joint dysfunction will be considered as selection failure. 
Second Visit 
In the second visit, the patient will be given the same ENT examination as in the initial 
visit. Parameters of interest will be measured (weight, height,BMI, and neck and waist 
circumferences), and the patients will complete the questionnaires. The patients will 
then be randomized to the control group or intervention group. Patients in the 
intervention group will be instructed about the use of the app and exercises to perform. 
The IOPI (model 2.1; IOPI Medical LLC, Carnation, WA) will be used to assess 
variables related to tongue function. The IOPI is a portable device that measures the 
amount of pressure exerted on a small air-filled bulb. The pressures obtained are 
expressed in kPa and displayed digitally on an LCD panel on the instrument. A series of 
LED lights representing percentages in 10% increments of a manually set pressure acts 
in combination with the built-in timer as a tool for measuring endurance. The IOPI has 
established high inter- and intrarater reliability and has been used to measure tongue 
function by our group in an earlier publication (11). To ensure accurate measurement, 
calibration is checked and adjusted if needed before use for each participant. A new 
bulb will be used for every participant because of hygiene and to minimize 

 
measurement error because of possible compliance variations in the bulb after extended 
use. 
The IOPI objectively measures maximum tongue and lip strength. Tongue 
strength is assessed by measuring the maximum pressure exerted when a person presses 
a disposable, standard-sized tongue bulb against the roof of the mouth. Lip strength is 
assessed by measuring the maximum pressure when the bulb is located between the 
cheek and closed teeth and the patient contracts the buccinator muscle without biting the 
bulb. Reference values have been obtained for a healthy population and are provided by 
the manufacturer (11). 
Tongue strength is measured by obtaining maximal tongue elevation pressures. 
The patient is instructed to “place this bulb in your mouth on the midline of your tongue 
and push it against the roof of your mouth as hard as you can.” To maximize standard 
placement, the examiner demonstrates how to place the bulb along the central groove of 
the tongue blade. Previous research (11) indicates that maximal measures of tongue 
strength and endurance are best assessed with an unconstrained jaw; participants will be 
encouraged to gently rest the incisors on the tubing of the IOPI bulb. Each test lasts 7–
10 s, and all participants will be given verbal encouragement from the examiner for the 
entire test. The test will be performed three times by each participant, with a brief rest of 
about 30 s between each test while the examiner records the peak pressure obtained. 
The highest pressure across the three trials will be used as the maximal isometric 
pressure (MIP) instead of the mean pressure, which is used by other researchers. Given 
the high correlation between the average and maximal pressure and that both are 
similarly related to oral-phase swallowing function, the use of the maximal pressure is 
more efficient in a clinical setting because it requires no calculation. (10) 

 
Follow-up Visits 
Intervention group. Patients in the intervention group will perform exercises for 
about 20 min daily. The patients will attend follow-up visits after 1 month (visit 3) and 
2 months later (visit 4). During these visits, the parameters of interest will be measured, 
patients will complete the questionnaires, and participants will be asked about their 
performance of the exercises. 
Control group. Patients in the control group will attend follow-up visits after 1 
month (visit 3) and 2 months later (visit 4). During these visits, the parameters of 
interest will be measured, patients will complete the questionnaires, and patients will 
confirm that no other therapies are being followed. 
Final visit. The final visit will be at 3 months in both groups. During this visit, the 
parameters of interest will be measured, patients in both groups will complete the 
questionnaires, and laboratory polysomnography will be performed. 
The total study duration for each patient will be 3 months. 
Discontinuation Criteria 
Patients will be excluded or discontinued from the study if they: 
1. do not perform 85% of the sessions (intervention group) 
2. are lost to follow-up for not attending hospital (both groups) 
3. lose 5% of body weight during the 3 months of the study (both groups). 
Statistical Analysis 
Data will be collected in a database. Nominal variables will be described by their 
frequency distribution. Quantitative variables will be assessed by calculating median 
and interquantile range . Baseline characteristics will be compared between groups 
using two-tailed paired t tests for continuous variables and the 2 or Fisher exact test for 

 
nominal variables. For variables with a skewed distribution, the Mann–Whitney U test 
will be used. Two-way repeated-measures analysis of variance and the Tukey test will 
be used to compare differences within and between groups in variables measured at the 
baseline and after 3 months. Pearson correlational analysis will be used to identify 
associations between changes in the AHI and changes in possible explanatory variables, 
including BMI, and waist and neck circumferences. A P value of 0.05 will be 
considered significant. IBM SPSS Statistics for Windows software (version 20; IBM 
Corp., Armonk, NY, USA) will be used for statistical analysis. 
The main parameters of interest will include polygraph findings at the beginning 
and end of the study, IOPI scores at the beginning and the end of the study, Epworth 
and Pittsburgh questionnaire scores at all visits, body weight (kg), height (cm), BMI 
(kg/m2), and neck and waist circumferences (cm) at all visits. 
Ethical Approval 
After evaluation by  the Investigation Ethical Committee and our revision of the 
protocol the study protocol was approved with the code AWGAPN-2019-01. Before 
starting the trial, all participants will be required to sign and date all consent forms, 
which have been approved by the ethical review committee. 
Access to Data and Data Protection 
To guarantee data confidentiality, the original data will be stored within each hospital 
and only the investigators and the Investigation Ethical Committee will have access to 
the data. This study is based on the ethical principles of the last revision of the Helsinki 
Declaration and Good Clinical Practice. All participants will be ensured of the 
confidentiality of all data (Organic Law Personal Data Protection 15/1999), and all 
information will be used only for the aims specified in the trial. Personal data that could 

 
identify patients will be separated from the rest of the information obtained in the trial. 
Every patient will have an identification number and this will be used instead of the 
name in the database. 
Utility 
This app may be helpful for improving the AHI and quality of life and for reducing 
clinical symptoms and the need for treatment in patients with OSAHS. 
Schedule 
Activity (months) 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Starting, database design, 
and coordination 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment 
 
 
 
 
 
 
 
 
 
 
 
 
Follow-up 
 
 
 
 
 
 
 
 
 
 
 
 
Data collection and entry 
into the database 
 
 
 
 
 
 
 
 
 
 
 
 
Statistical analysis and 
reporting results 
 
 
 
 
 
 
 
 
 
 
 
 
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Myofunctional therapy to treat obstructive sleep apnea: a systematic review and 
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anatomy on snoring and sleep apnoea. J Pak Med Assoc 2015;65:125–130. 
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Morente JC, Gonzalez ED, Rodriguez-Reina A. New mHealth application software 
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5. Isetta V, Torres M, González K, Ruiz C, Dalmases M, Embid C, Navajas D, Farré R, 
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Capasso R. Smartphone apps for snoring. J Laryngol Otol 2015;129:974–979. 
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Magalang UJ. Comparative efficacy of CPAP, MADs, exercise-training, and dietary 
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         EXERCISES AND VIDEOS 
 
         In all exercises, due to hygienical reasons we recommend to cover the screen with cling 
film or a cleaning wipe 
 
 Exercise 1. Chromatic snake.  
With your elbows touching your body, hold the phone with both hands as you do when 
holding a mirror in front of your face. 
Attend the the order of the lights and music. Stick your tongue out and press the screen with 
it following the preceding order of the lights. 
Repeat the exercise 15 times. 
Exercise 2. Snake  
With your elbows touching your body, hold the phone with both hands as you do when 
holding a mirror in front of your face. 
Stick your tongue out and press the screen with it for 5 s and release. The tongue should not 
touch your teeth or lips. 
Repeat the exercise 15 times. 
Exercise 3. Chameleon up  
Place the phone at a certain distance in front of you, as if it were a mirror. Stick out your 
tongue and press on the square at the bottom. The tongue must not touch your teeth or lips. 

 
Put your tongue up and keep the pressure on the screen 5 s, close your mouth and rest. 
Repeat the exercise 15 times. 
 
Exercise 4. Chameleon down. 
Place the phone at a certain distance in front of you, as if it were a mirror. Stick out your 
tongue and press on the square at the bottom. The tongue must not touch your teeth or lips. 
Put your tongue down and keep pressing the screen for 5 s, close your mouth and rest. 
Repeat the exercise 15 times. 
Exercise 5. Tongue left cheek. 
 Press with the tip  of your tongue the inside of the left cheek. Allow the screen of your 
phone to touch gently your cheek. 
Contract the muscles of your cheek while pushing with the tongue towards the cheek. Keep the 
pressure for 5 s. 
Repeat the exercise 15 times. 
Exercise 6. Tongue right cheek 
 Press with the  tip of your tongue the inside of the right cheek. Allow the screen of your 
phone to touch gently your cheek. 
Contract the muscles of your cheek while pushing with the tongue towards the cheek. Keep the 
pressure for 5 s. 
Repeat the exercise 15 times. 
Exercise 7. Pressure under chin.  
Hold the phone with both hands with the screen facing up. If you’ve got a beard place your 
finger between your phone and your jaw. 
Sitting upright put the phone under your chin so there is no contact with the chin. 
Bend your head forward like you are going to drink from a cup and contact your chin on 

 
the phone. 
Keep the contact and move your head from side to side during 10 s with your mouth closed. 
Lift your head and rest. Repeat the exercise 15 times. 
Exercise 8. Left mandibular pressure.  
Bring the phone closer to the origin of the jaw on the left side. As if you were talking on the 
phone but with the screen to the outside. 
Turn your jaw towards the phone and keep the pres- sure with your index finger on the screen 
for 5 s. Say /i/ while doing it. Release the pressure and rest. Repeat the process 15 times. 
Exercise 9. Right mandibular  pressure .  
Bring the phone closer to the origin of the jaw on the right side. As if you were talking on the 
phone but with the screen to the outside. 
Turn your jaw towards the phone and keep the pressure with your index finger on the screen 
for 5 s. Say /i/ while doing it. 
 
 
 
 
 
 
 
 
 
FIGURES LEGEND: 
FIGURE 5,6,7 Gif instructions about teaching movement 
FIGURES 8,9,10 Evolution of exercises daily weekly and during the year 
FIGURE 11 : Reward obtained once finishing exercises 
FIGURE 12: Trainer control of the exercises.