Evaluation of muscle activity patterns in patients with severe obstructive sleep apnea
| ISRCTN | ISRCTN12596010 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12596010 |
| Secondary identifying numbers | AWGAP-2021-02 |
- Submission date
- 20/03/2021
- Registration date
- 24/03/2021
- Last edited
- 27/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Obstructive Sleep Apnoea/Hypopnoea Syndrome (OSAHS) is a condition whereby the upper airways collapse intermittently and repeatedly during sleep. This can vary between an apnoea (no airflow through the airways) and a hypopnoea (a reduction of airflow through the airways).
Deciding the best course of treatment for OSAHS can be difficult without knowing which muscles are not working correctly. A relatively new technique for visually assessing the muscles is called the OMES protocol (Orofacial Myofunctional Evaluation Protocol with Scores).
The aim of this study is to compare the OMES protocol with other available measures of tongue muscle strength.
Who can participate?
Patients diagnosed with sleep apnoea-hypopnoea at the participating hospitals
What does the study involve?
Selection visit: an initial sleep study (with measurement of baseline AHI, night-time oxygen desaturation index and the lowest night-time oxygen saturation figures)
One-off visit: The patient is evaluated by the speech therapist and fills in the sleepiness questionnaires, following which the OMES protocol is applied and the evaluation is carried out with the IOPI (Iowa Oral Performance Instrument) and the digital spoon.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Hospital Quironsalud Marbella (Spain)
When is the study starting and how long is it expected to run for?
March 2021 to September 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Carlos O'Connor Reina, coconnor@us.es.
Contact information
Scientific
Avda Menendez y Pelayo 44 5c
Sevilla
41003
Spain
 ORCID ID |
0000-0002-1670-4235 |
|---|---|
| Phone | +34 952774200 |
| carlos.oconnor@quironsalud.es |
Study information
| Study design | Prospective controlled quasi-experimental pilot study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | ISRCTN12596010_PIS.docx |
| Scientific title | Validation of Orofacial Myofunctional Evaluation Protocol with Scores (OMES) with objective measurement of oropharyngeal muscle tone using Iowa Oral Performance Instrument (IOPI) and tongue digital spoon in severe obstructive sleep apnea hypopnea syndrome (OSAHS) |
| Study acronym | OMESIOPITDS |
| Study objectives | The use of the OMES protocol can be complemented by the values obtained through the IOPI instruments and the tongue digital spoon in severe OSAHS patients. |
| Ethics approval(s) | Approved 17/03/2021, The Research Ethics Committee of the Hospital Provincial de Málaga (Regional University Hospital, 7th floor Pabellón A, Avda. –Carlos Haya s / n. 29010-Malaga, Spain; +34 951 29 1447; no email address available), ref: AWGAP-2021-02 |
| Health condition(s) or problem(s) studied | Sleep apnoea, severe obstructive sleep apnea-hypopnea syndrome |
| Intervention | A myofunctional evaluation of the patient diagnosed with OSAHS will be conducted in the same week as the polysomnography is performed. During this evaluation, patients are blindly examined by a speech therapist and their examination is recorded on video for later evaluation. The patient will sit one metre away from the camera with their feet flat on the floor and their back supported by the backrest. The camera (Sony CCD-TRV138 Handycam camcorder: Sony Electronics, San Diego, CA 92127, USA) will be placed on a tripod at face and shoulder height. The evaluation with the OMES protocol (Annex 4) will then take place, based on the analysis of the following parameters: 1. Appearance/posture 2. Mobility 3. Functions 3.1. Respiration 3.2. Deglutition 3.3. Mastication As a result of this evaluation with the already validated protocol, the higher the score, the more normal the patient's stomatognathic system. Subsequently, the muscle tone of the genioglossus muscle and the buccinator muscle are evaluated, taking three measurements of each one and using the highest value. Finally, the tone of the tongue muscles is measured with the digital spoon, taking three measurements and using the highest one. The recordings and the data obtained will also be blindly analysed by another examiner. |
| Intervention type | Other |
| Primary outcome measure | Function of the stomatognathic musculature of patients measured a single time point using: 1. The OMES protocol (visual inspection) 2. The digital spoon to measure tongue pressure 3. The IOPI (Iowa Oral Performance Instrument) to measure tongue strength and resistance with the genioglossus and buccinator muscle tone |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 18/03/2021 |
| Completion date | 18/09/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 49 |
| Key inclusion criteria | Current inclusion criteria as of 29/03/2021: Cases: 1. Ages between 18 and 75 years 2. Diagnosis of moderate to severe OSAHS (AHI>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 Controls: 1. Adequate sleep hygiene 2. No complaints of snoring 3. No complaints of daytime sleepiness 4. Epworth Scale <7 points Previous inclusion criteria: Cases: 1. Ages between 18 and 75 years 2. Diagnosis of moderate to severe OSAHS (AHI>15) 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 Controls: 1. Adequate sleep hygiene 2. No complaints of snoring 3. No complaints of daytime sleepiness 4. Epworth Scale <7 points |
| 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, CPAP) |
| Date of first enrolment | 07/04/2021 |
| Date of final enrolment | 17/09/2022 |
Locations
Countries of recruitment
- Spain
Study participating centres
Marbella
29603
Spain
Palmones Cadiz
11379
Spain
Sponsor information
Hospital/treatment centre
Avda Severo Ochoa 22
Marbella
29603
Spain
| Phone | +34 972774200 |
|---|---|
| investigacion.mlg@quironsalud.es | |
| Website | https://www.quironsalud.es |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 21/09/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | We want to publish results in a high impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 24/03/2021 | No | Yes | ||
| Protocol file | 24/03/2021 | No | No | ||
| Protocol article | 01/06/2021 | 14/06/2021 | Yes | No | |
| Results article | 07/02/2023 | 27/02/2023 | Yes | No |
Additional files
- ISRCTN12596010_PROTOCOL_no_date.docx
- uploaded 24/03/2021
- ISRCTN12596010_PIS.docx
- uploaded 24/03/2021
Editorial Notes
27/02/2023: Publication reference added.
27/09/2022: The total final enrolment was added.
14/06/2021: Publication reference added.
19/04/2021: The ethics approval has been added.
29/03/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 19/03/2021 to 07/04/2021.
2. The inclusion criteria were updated.
24/03/2021: The following changes were made to the trial record:
1. The participant information sheet was uploaded as an additional file.
2. Uploaded protocol (not peer-reviewed) as an additional file. Version n/a, no date.
23/03/2021: Trial's existence confirmed by The Research Ethics Committee of the Hospital Provincial de Málaga.
