Condition category
Nervous System Diseases
Date applied
16/05/2020
Date assigned
19/05/2020
Last edited
19/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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, coconnor@us.es

Trial website

Contact information

Type

Scientific

Primary contact

Dr Carlos O´Connor Reina

ORCID ID

https://orcid.org/0000-0002-1670-4235

Contact details

Avenida Menendez y Pelayo 44 5c
Sevilla
41003
Spain
+34 658059669
coconnor@us.es

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

AWGAPN-2019-01

Study information

Scientific title

Effects of myofunctional therapy with an m-health application airway gym in severe apnea/hypopnea sleep obstructive syndrome. A randomized multicentre control trial

Acronym

MTASSAOS

Study hypothesis

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.

Ethics approval

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; cto@hcs.es), ref: 81-01-2019

Study design

Interventional prospective multicentre trial with consecutive random assignment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not avalaible in web format pleas use contact details to request a participant information sheet

Condition

Severe sleep apnea/hypopnea syndrome

Intervention

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.

Intervention type

Behavioural

Phase

Drug names

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

01/10/2018

Overall trial end date

01/07/2020

Reason abandoned (if study stopped)

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

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
7. Stroke
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

01/02/2019

Recruitment end date

01/06/2020

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Quironsalud Marbella
Avda Severo Ochoa 22
Marbella
29603
Spain

Trial participating centre

Hospital Quironsalud Campo de Gibraltar
Edificio Artysur PE Las Marismas de Palmones
Palmones-Los Barrios
11379
Spain

Sponsor information

Organisation

Hospital Quironsalud Marbella

Sponsor details

Avenida Severo Ochoa 22
Marbella
29603
Spain
+34 952774282
carlos.oconnor@quironsalud.es

Sponsor type

Hospital/treatment centre

Website

http://www.quironsalud.es

Funders

Funder type

Other

Funder name

investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

01/08/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

19/05/2020: Trial’s existence confirmed by Ethical Committee Costa del Sol Hospital