Plain English Summary
Background and study aims
Obstructive sleep apnea is a potentially serious sleep disorder. It causes breathing to repeatedly stop and start during sleep.
There are several types of sleep apnea, but the most common is obstructive sleep apnea. This type of apnea occurs when your throat muscles intermittently relax and block your airway during sleep.
The classic treatment of this disease is based on dietary measures, losing weight, and exercise, and the use of a continuous positive airway pressure (CPAP) machine (a device that reduces collapsibility of the upper airway by emitting a flow of air). Other options are upper airway surgery treating the obstacle of the airway or correcting the muscles that do not perform their function properly, and mandibular advancement devices (MAD), which push the tongue forward to avoid it falling backward and collapsing the airway.
Myofunctional therapy (MT) has become one of the newest treatments for sleep-disordered breathing. MT is based on daily exercises of the throat muscles in an attempt to strength them and facilitate opening of the airway.
Who can participate?
Patients diagnose with sleep apnea and aged between 18 – 75 years.
What does the study involve?
Participants will be randomly allocated to either use of the ‘Airway gym’ smartphone app or treatment as usual for three months. The airway gym app provides instructions on how to perform exercises to strengthen the throat muscles and also reminds participants to perform the exercises for 20 minutes per day. Each month participants will be assessed at the clinic.
What are the possible benefits and risks of participating?
Benefits: Curing sleep apnea syndrome.
There are no signficant risks for participants.
Where is the study run from?
Hospital Quironsalud Marbella (Spain)
When is the study starting and how long is it expected to run for?
October 2018 to July 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Carlos O’Connor Reina, firstname.lastname@example.org
Effects of myofunctional therapy with an m-health application airway gym in severe apnea/hypopnea sleep obstructive syndrome. A randomized multicentre control trial
The periodical use of the app 'Airway Gym' designed to perform and increase adherence in Myofunctional therapy (MT), improve obstructive sleep apnea/hypopnea syndrome ( OSAHS) in patients with severe disease (AHI>30) increasing the tone of the upper airway muscles.
Approved 01/02/19, Ethical Committee Costa del Sol Hospital (Comité de Ética de Investigación Área Costa del Sol, Hospital Costa del Sol
Autovía del Mediterráneo, Km 187, 29603, Marbella (Málaga), Spain; +34 951976620; email@example.com), ref: 81-01-2019
Interventional prospective multicentre trial with consecutive random assignment
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not avalaible in web format pleas use contact details to request a participant information sheet
Severe sleep apnea/hypopnea syndrome
Experimental group: Myofunctional exercises based on a mHealth App AirwayGym daily performed during 3 months 20 minutes a day.
Control group: No intervention.
Patients will be randomized consecutively.
Primary outcome measure
At baseline and 3 months:
1. Severity of apnea measured using The Apnea–Hypopnea Index
2. Saturation O2 and Nadir O2 measured using oximeter
3. Tongue strength measured using the Iowa Oral Performance Instrument (IOPI)
Secondary outcome measures
Measured each month for 3 months:
1. Sleep quality measured using Pittsburgh Sleep Quality Index (PSQI)
2. Sleepiness measured using Epworth sleepiness scale
3. BMI (kg/m²)
4. Neck and waist circumference (cm)
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Age between 18-75 years
2. Recently diagnosed with severe sleep apnea and do not have any previous experience or information with this pathology
3. Consent signed
Target number of participants
Participant exclusion criteria
1. IMC (BMI) > 40 kg/m²
2. Inability to fill up questionnaires
3. Severe drug or alcohol abuse
4. Hypnotic medication
5. Not controlled coronary disease
6. Decompensated Heart failure
8. Systemic Disease associated with inflammatory diagnosed entity (arthritis, sarcoidosis, vasculitis, lupus…)
9. Neuromuscular disease (like Duchenne)
10. Craniofacial deformities.
11. Active oncologic process.
12. Any antecedents of MT treatment or other treatment for sleep apnea could affect study results of the study (surgery, DAM or CPAP).
Once the patient accepted and signed consent and met inclusion criteria, they will be attended by Ent specialist to rule out:
13. Severe upper airway obstruction (Complete nose obstruction, Tonsills grade IV/IV )
14. Presence of tongue tie (Marchesani Protocole) with limitation of tongue movements
15. Antecedents or presence of temporomandibular joint disorders
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Hospital Quironsalud Marbella
Avda Severo Ochoa 22
Trial participating centre
Hospital Quironsalud Campo de Gibraltar
Edificio Artysur PE Las Marismas de Palmones
investigator initiated and funded
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
We will try to publish in high impact factor journals of sleep and pulmonology research.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality.
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
- ISRCTN90694424_PROTOCOL_19May20.pdf Uploaded 08/06/2020