The effects of an m-health application for exercising the mouth and facial muscles in patients with sleep obstructive syndrome
| ISRCTN | ISRCTN90694424 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90694424 |
| Secondary identifying numbers | AWGAPN-2019-01 |
- Submission date
- 16/05/2020
- Registration date
- 19/05/2020
- Last edited
- 03/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
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 November 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Carlos O’Connor Reina, coconnor@us.es
Contact information
Scientific
Avenida Menendez y Pelayo 44 5c
Sevilla
41003
Spain
 ORCID ID |
0000-0002-1670-4235 |
|---|---|
| Phone | +34 658059669 |
| coconnor@us.es |
Study information
| Study design | Interventional prospective multicentre trial with consecutive random assignment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not avalaible in web format pleas use contact details to request a participant information sheet |
| 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 |
| Study 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(s) | 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 |
| 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 |
| 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 study start date | 01/10/2018 |
| Overall study end date | 01/10/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 40 |
| 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 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 | 15/09/2020 |
Locations
Countries of recruitment
- Spain
Study participating centres
Marbella
29603
Spain
Palmones-Los Barrios
11379
Spain
Sponsor information
Hospital/treatment centre
Avenida Severo Ochoa 22
Marbella
29603
Spain
| Phone | +34 952774282 |
|---|---|
| carlos.oconnor@quironsalud.es | |
| Website | http://www.quironsalud.es |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/11/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Current publication and dissemination plan as of 18/09/2020: We will try to publish in high-impact-factor journals of informatics, sleep and pulmonology research. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality. _____ Previous 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 19/05/2020 | 08/06/2020 | No | No | |
| Results article | results | 09/11/2020 | 03/11/2020 | Yes | No |
Additional files
- ISRCTN90694424_PROTOCOL_19May20.pdf
- Uploaded 08/06/2020
Editorial Notes
03/11/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
18/09/2020: The following changes have been made:
1. The recruitment end date has been changed from 15/10/2020 to 15/09/2020.
2. The overall trial end date has been changed from 01/11/2020 to 01/10/2020.
3. The publication and dissemination plan has been changed.
11/09/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 15/07/2020 to 15/10/2020.
2. The overall trial end date was changed from 01/09/2020 to 01/11/2020.
3. The intention to publish date was changed from 01/08/2020 to 01/11/2020.
05/08/2020: The overall end date was changed from 01/07/2020 to 01/09/2020.
06/07/2020: The recruitment end date was changed from 01/06/2020 to 15/07/2020.
08/06/2020: Uploaded protocol 19 May 2020 (not peer reviewed).
19/05/2020: Trial’s existence confirmed by Ethical Committee Costa del Sol Hospital
