How muscle exercise affects the amount of fat in the tongue of patients with obstructive sleep apnea, using ultrasound to measure the changes
| ISRCTN | ISRCTN92645461 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92645461 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | AWGAP-20232 |
| Sponsor | Hospital Quironsalud Marbella |
| Funder | Investigator initiated and funded |
- Submission date
- 04/03/2023
- Registration date
- 09/03/2023
- Last edited
- 28/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Sleep apnea is a sleep disorder characterized by breathing interruptions during sleep. It occurs when the muscles in the back of the throat fail to keep the airway open, causing a person to stop breathing for a brief period of time. These interruptions can last from a few seconds to a few minutes and may occur many times during the night. Obstructive sleep apnea is the most common type and occurs when the muscles in the back of the throat relax and block the airway.
Myofunctional therapy is a type of exercise therapy that aims to improve the function of the muscles in the face, mouth, and throat. It involves exercises that are designed to improve breathing, swallowing, and speech, and can be used to treat a range of conditions such as sleep apnea, speech disorders, and TMJ disorders. The therapy may involve exercises that target the tongue, lips, cheeks, and jaw muscles, as well as breathing exercises and postural adjustments.
This study examines how myofunctional therapy affects the amount of fat in the tongue of patients with obstructive sleep apnea, using ultrasound to measure the changes.
Who can participate?
Patients aged 18 - 75 years with obstructive sleep apnea.
What does the study involve?
Participants will be randomly allocated to one of three groups:
Control group. Patients with recent moderate-severe sleep apnea (1-3 months) undergoing treatment with postive pressure therapy (CPAP). An initial ultrasound measurement of tongue genioglossus fat will be made and 3 months after inclusion in the study.
MT group - moderate apnea. Only and exclusively MT exercises once a day for 3 months through the AirwayGym application. An initial ultrasound measurement and DISE will be made with control at 3 months.
MT-CPAP severe apnea group. They will use CPAP at night, measuring the number of hours they use it at night. A new sleep study will be performed at 3 months. An initial ultrasound measurement and DISE will be made with control at 3 months.
What are the possible benefits and risks of participating?
The potential benefits are to improve his sleep apnea disease in order to demonstrate another therapy goal to be treated as is the tongue fat measured by ultrasound.
There will be no risks for no participation as all the patients are receiving recognized treatment.
Where is the study run from?
Hospital Quiron Salud Marbella (Spain)
When is the study starting and how long is it expected to run for?
October 2022 to September 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Carlos O'Connor, carlos.oconnor@quironsalud.es
Contact information
Principal investigator
Avda Severo Ochoa 22
Marbella
29603
Spain
 ORCID ID |
0000-0002-1670-4235 |
|---|---|
| Phone | +34 952780540 |
| carlos.oconnor@quironsalud.es |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicenter randomized quasi-experimental controlled prospective pilot study |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 43316 PIS.pdf |
| Scientific title | Influence of oropharyngeal exercises in genioglossus fat measured by ultrasound in sleep apnea patients |
| Study acronym | TONGUEFATULTRASOUNDMT |
| Study objectives | Neck ultrasound is useful to better assess the response to MT treatment than tools that only measure muscle strength. |
| Ethics approval(s) | Approved 23/02/2023, Malaga Comite de Ética de la Investigación Provincial de Malaga (Hospital Universitario Regional de Málaga Carlos Haya, Malaga, Spain; +34951 291 977; eticainvestiga.hch.sspa@juntadeandalucia.es), ref: AWAGP-20232 |
| Health condition(s) or problem(s) studied | Sleep apnea |
| Intervention | Participants are randomised into groups using an online tool. 1. Control group. Patients with recent moderate-severe sleep apnea (1-3 months) undergoing treatment with postive pressure therapy (CPAP). An initial ultrasound measurement of tongue genioglossus fat will be made and 3 months after inclusion in the study. 2. MT group - moderate apnea. Only and exclusively MT exercises once a day for 3 months through the AirwayGym application. An initial ultrasound measurement and DISE will be made with control at 3 months. 3. MT-CPAP severe apnea group. They will use CPAP at night, measuring the number of hours they use it at night. A new sleep study will be performed at 3 months. An initial ultrasound measurement and DISE will be made with control at 3 months. DISTRIBUTION OF VISITS TO THE CENTER: The visits during the study are distributed as follows: SELECTION VISIT: In patients diagnosed with OSA in a pulmonology laboratory through an initial sleep study (with baseline AHI measurement, nocturnal desaturation index, and the lowest 02 saturation figures during the night), the inclusion and exclusion criteria obtained through the sleep study, they are informed about the study and after reading and resolving their doubts, the patient accepts and signs the IC in duplicate, taking a copy home. ENT VISIT: The patient is assessed by the otolaryngologist and if he meets the anatomical inclusion criteria, he becomes part of one of the study groups for initial DISE and lingual force measurements with IOPI and digital spoon. ULTRSOUND VISIT. A neck ultrasound will be performed, which will include the measurements of the ultrasound intensity, width and height of the tongue measured in initial mm prior to the initial DISE. MONTHLY CONTROL BY TELEMEDICINE. During the 3 months of the study, each patient in the 3 groups will be monitored for adherence and incidents to the prescribed treatment. CONTROL 3 MONTHS. A measurement of all the variables evaluated at the initial visit will be repeated. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Tongue fat measured in millimeters by ultrasound pre and post-oropharyngeal exercises (baseline and 3 months) |
| Key secondary outcome measure(s) |
Measured pre and post-oropharyngeal exercises (baseline and 3 months): |
| Completion date | 01/09/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 45 |
| Key inclusion criteria | 1. Aged between 18-75 years. 2. Diagnosis of moderate-severe OSA (iah>15). 3. Not having used any previous treatment other than that of the study or lasting longer than 3 months in the case of the control group. 4. Signature of informed consent (IC). 5. Present good permeability and nasal function. 6. BMI < 30 kg/m². |
| Key exclusion criteria | 1. Cognitive or neurological deficit. 2. Inability to complete questionnaires. 3. Severe alcoholism. 4. Presence of craniofacial malformations. 5. Active neoplastic disease. 6. History of previous rehabilitation treatment of the orofacial musculature as well as any other treatment for previous apnea that could modify the results of the study (Surgery, MAD). 7. Temporomandibular joint dysfunction 8. Ankyloglossia of the tongue or inability to perform MT exercises. 9. Not having a smartphone or inability to manipulate it, or internet network at home. 10. BMI >30 kg/m² 11. Weight changes with an increase of more than 5kg during the 3 months of study. |
| Date of first enrolment | 30/04/2023 |
| Date of final enrolment | 01/05/2025 |
Locations
Countries of recruitment
- Spain
Study participating centres
Marbella
29603
Spain
Palmones
11379
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from (Dr Carlos O'Connor-Reina carlos.oconnor@quironsalud.es |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 30/01/2024 | 15/05/2024 | Yes | No | |
| Participant information sheet | 09/03/2023 | No | Yes | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 43316 PIS.pdf
- Participant information sheet
Editorial Notes
28/01/2025: The following changes were made:
1. The recruitment end date was changed from 01/01/2025 to 01/05/2025.
2. The overall study end date was changed from 30/06/2025 to 01/09/2025.
24/10/2024: The recruitment end date was changed from 30/10/2024 to 01/01/2025.
15/05/2024: The following changes were made:
1. Publication reference added.
2. The overall study end date was changed from 30/03/2025 to 30/06/2025.
3. The recruitment end date was changed from 30/05/2024 to 30/10/2024.
4. The intention to publish date was changed from 23/03/2025 to 23/06/2025.
12/12/2023: The recruitment end date was changed from 31/12/2023 to 30/05/2024.
09/03/2023: Trial's existence confirmed by Malaga Comite de Ética de la Investigación Provincial de Malaga.
