Effect of throat exercises in lower jaw advancement to treat sleep apnea
| ISRCTN | ISRCTN13128082 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13128082 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | AWAGAP-2023-1 |
| Sponsor | Quirons salud investigacion |
| Funder | Investigator initiated and funded |
- Submission date
- 14/04/2023
- Registration date
- 17/04/2023
- Last edited
- 09/05/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is a condition in which the upper airway is narrowed or closes during sleep when muscles relax, causing under-breathing or stopping breathing. Myofunctional therapy (MT) is a treatment option for OSAHS based on performing regular exercises with the upper airway muscles in order to increase their tone of them and prevent their collapsibility. Mandibular advancement devices (MADs) are used for OSAHS treatment creating a tongue and jaw protrusion and causing changes in the upper airway (UA) widening its dimensions. The aim of this study is to determine the effectiveness of and adherence to upper airway muscle exercises performed with an App (Airway Gym) in patients with moderate OSAHS who use a MAD.
Who can participate?
Patients aged between 18 and 75 years with moderate OSA
What does the study involve?
Participants are randomly allocated to one of four groups. One group will undergo sham therapy. Another group will have to use an app to perform myofunctional exercises and another will do exercises with a MAD and another will have to wear a MAD for OSA treatment for 3 months. Patients will be examined and the tone of the upper airway muscles is measured with a tongue digital spoon device. Polysomnography (sleep study) will be repeated after 3 months in all the groups. A sleep diary will be provided to patients to measure adherence.
What are the possible benefits and risks of participating?
The benefits will come from improvements in OSAHS symptoms. The researchers hope no risks will be involved.
Where is the study run from?
Grupo Quironsalud (Spain)
When is the study starting and how long is it expected to run for?
January 2023 to March 2026
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Carlos O'Connor-Reina, carlos.oconnor@quironsalud.es
Contact information
Principal investigator
Avda menendez y Pelayo 44 5c
Sevilla
41003
Spain
 ORCID ID |
0000-0002-1670-4235 |
|---|---|
| Phone | +34 (0)952780540 |
| carlos.oconnor@quironsalud.es |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective controlled randomized clinical trial pilot study |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 43496_PIS.pdf |
| Scientific title | Influence of oropharyngeal exercises in the adherence and efficacy of mandibular advancement device therapy in patients with moderate obstructive sleep apnea: a multicentre randomized clinical trial pilot study |
| Study acronym | MADOMTCOMPLIANCE |
| Study objectives | The main objective will be to evaluate the changes in apnea-hypopnea index (AHI), oxygen desaturation index (ODI) and minimal O2 desaturation (min sat o2) after 3 months of myofunctional therapy (MT) with an App in moderate sleep apnoea patients that use a mandibular advancement device (MAD) (Noa® from Orthopnoea®). The secondary objectives will be: 1. If the use of MAD modifies the strength of the genioglossus muscle measured by TDS and IOPI 2. If oropharyngeal exercises increase subjective parameters measured with Epworth, VAS and Pittsburgh questionnaires 3. If oropharyngeal exercises increase adherence to the use of MAD 4. If prior score obtained with TDS and IOPI can influence adherence or efficacy of MAD 5. If oropharyngeal exercises increase objective measures obtained with TDS and IOPI 6. If oropharyngeal exercises create any morbidity in patients with MAD (adverse effects) |
| Ethics approval(s) | Approved 12/04/2023, Comite de Ética de Investigación de Malaga Hospital Regional Universitario (7ª planta Pabellón A, Avda. –Carlos Haya s/n, 29010, Málaga, Spain; +34 (0)951 29 1447 / +34 (0)951 29 1977; portaldeetica.csalud@juntadeandalucia.es), ref: 0324-N-23 |
| Health condition(s) or problem(s) studied | Sleep apnea |
| Intervention | A myofunctional and anatomical evaluation of the patient diagnosed with obstructive sleep apnea/hypopnea syndrome (OSAHS) will be conducted in the same week as the polysomnography is performed. During this evaluation, patients are blindly examined by an otorhinolaryngologist and blindly allocated to each group. Randomization will be simple randomization depending on the order the patient attends the Ear, Nose and Throat (ENT) consultation. The total duration of therapy will be 3 months. There will be four arms: 1. Sham therapy: expiratory exercises daily performed and written in a diary. 2. Myofunctional therapy: oropharyngeal exercises performed by an APP Airway Gym followed by telemedicine 3. Mandibular advancement device therapy: use of a titratable mandibular advancement device (NOA device) 4. Mandibular advancement device and oropharyngeal exercises: a combination of both Subsequently, the muscle tone of the genioglossus muscle and the buccinator muscle are evaluated with IOPI, taking three measurements of each one and using the highest value. The tone of the tongue muscles is measured with the digital spoon, taking three measurements and using the highest one. Then is referred to the dentist to adapt MAD at the maximum distance allowed. DISTRIBUTION OF HOSPITAL VISITS: Visits during the study are distributed as follows: SELECTION VISIT: The patient diagnosed with OSAHS at a pulmonology laboratory by means of an initial sleep study (with measurement of baseline AHI, night-time oxygen desaturation index and the lowest night-time oxygen saturation figures) is evaluated vis-à-vis the inclusion and exclusion criteria and then informed about the study. After reading the information and having any doubts solved, the patient accepts and signs the informed consent form in duplicate, taking one copy home. ONE-OFF VISIT: The patient is evaluated by the otolaryngologist and fills in the sleepiness questionnaires, the TDS and IOPI. Exercises are explained and the group with MAD is referred to the dentist to provide the MAD. FINAL VISIT: After 3 months there is another sleep study with anatomical measurements and questionnaires. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Apnea-hypopnea index (AHI) measured by polysomnography/polygraphy measured on the first day and after 3 months |
| Key secondary outcome measure(s) |
Measured on the first day and after 3 months (except for sleep diary): |
| Completion date | 05/03/2026 |
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 | 48 |
| Key inclusion criteria | 1. Aged between 18 and 75 years 2. Diagnosis of moderate OSAHS (AHI between 15-30) without having had previous experience of said condition and not undergoing treatment due to different circumstances 3. Not having undergone any previous treatment for OSAHS 4. Signed informed consent (IC) form |
| Key exclusion criteria | 1. Cognitive or neurological deficit 2. Inability to answer questionnaires 3. Severe alcoholism 4. Presence of craniofacial malformations 5. Active neoplastic disease 6. History of prior orofacial muscle rehabilitation therapy and any prior apnoea treatment which may modify the study results (surgery, MAD, continuous positive airway pressure [CPAP]) 7. Not having a smartphone 8. Temporomandibular joint dysfunction 9. Absence of dentition to wear a MAD |
| Date of first enrolment | 03/05/2023 |
| Date of final enrolment | 05/12/2025 |
Locations
Countries of recruitment
- Spain
Study participating centres
Marbella
29603
Spain
Palmones, Cadiz
11370
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 (carlos.oconnor@quironsalud.es). Data will be available on 01/01/2026. The type of data that will be shared: raw data. Consent will be obtained from all participants. Data will be collected anonymously. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 17/04/2023 | No | Yes | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 43496_PIS.pdf
- Participant information sheet
Editorial Notes
09/05/2025: The following changes were made to the study record:
1. The recruitment end date was changed from 01/09/2024 to 05/12/2025.
2. The overall study end date was changed from 03/05/2025 to 05/03/2026.
17/04/2023: Trial's existence confirmed by the Comite de Ética de Investigación de Malaga.
