Validation of a low cost manometer to evaluate upper airway oropharyngeal muscle strength
| ISRCTN | ISRCTN49446863 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49446863 |
| Secondary identifying numbers | AWGAP-2024-2 |
- Submission date
- 04/05/2025
- Registration date
- 06/05/2025
- Last edited
- 06/05/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
Background and study aims
Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS) is a condition where people experience repeated episodes of blocked breathing during sleep. This can lead to snoring, poor sleep quality, daytime sleepiness, and increased risk of heart problems. The most effective treatment is Continuous Positive Airway Pressure (CPAP), but not everyone sticks with it. This study aims to find out if using certain tools to measure muscle strength in the mouth and throat can help improve treatment for OSAHS.
Who can participate?
Adults aged 18 to 75 who have been diagnosed with moderate to severe OSAHS and have not received any prior treatment can participate. Healthy adults with good sleep habits and no complaints of snoring or daytime sleepiness can also participate as control subjects.
What does the study involve?
Participants will undergo various tests to measure the strength of their mouth and throat muscles using tools like the IOPI device, a digital manometer, and a digital spoon. They will also complete questionnaires about their sleep and muscle function. These tests will be done during a single visit to the hospital.
What are the possible benefits and risks of participating?
There are no expected side effects or complications from participating in this study. The tests are routine assessments commonly done in speech therapy and dysphagia units. Participants may benefit from gaining a better understanding of their condition and contributing to research that could improve treatment for OSAHS.
Where is the study run from?
Quirónsalud Hospital in Marbella and Hospital Campo de Gibraltar (Spain)
When is the study starting and how long is it expected to run for?
January 2025 to April 2026
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Carlos O'Connor, carlos.oconnor@quironsalud.es
Contact information
Public, Scientific, Principal Investigator
Hospital Quironsalud Marbella, avda severo ochoa 22
Marbella
29603
Spain
 ORCID ID |
0000-0002-1670-4235 |
|---|---|
| Phone | +34 952780540 |
| carlos.oconnor@quironsalud.es |
Study information
| Study design | Prospective controlled quasi-experimental pilot study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Comparative diagnostic validation study |
| Study setting(s) | GP practice, Hospital |
| Study type | Prevention, Quality of life, Screening |
| Participant information sheet | 47275 PIS.pdf |
| Scientific title | Validation of the OMES questionnaire compared to objective measurement of oropharyngeal muscle tone using the IOPI manometer, Sandway manometer, and digital spoon |
| Study acronym | LCTM |
| Study objectives | The use of the OMES questionnaire can be complemented by the values obtained through measurement instruments such as the IOPI device, digital manometer, and digital spoon. |
| Ethics approval(s) |
Approved 27/03/2025, CEIm Provincial de Málaga (Hospital Regional Universitario Carlos Haya. Avda Carlos Haya 84. Pabellon a.Hospital General 7 planta, Malaga, 29010, Spain; +34 951291977; eticainvestiga.hch.sspa@juntadeandalucia.es), ref: SICEIA-2024-002767 |
| Health condition(s) or problem(s) studied | Obstructive sleep apnea |
| Intervention | Participants are enrolled after signing informed consent and screened to confirm eligibility (OSAHS diagnosis for cases; good sleep hygiene and absence of symptoms for controls). The study consists of a single evaluation visit taking place during the same week as the patient’s sleep study. During this visit, participants complete the OMES questionnaire and undergo muscle tone assessments using the IOPI® manometer, Sandway® manometer, and a digital spoon. All tests are performed by a trained speech therapist and recorded for later blinded assessment. The total duration of observation is approximately 1 hour. There is no longitudinal follow-up; data collection is completed in a single session. |
| Intervention type | Other |
| Primary outcome measure | Orofacial muscle function measured using the OMES questionnaire at baseline (single visit). |
| Secondary outcome measures | 1. Tongue and buccinator muscle strength measured using the IOPI® manometer at baseline (single visit). Measured in kilopascals (kps). 2. Tongue pressure measured using the Sandway® manometer at baseline (single visit). Measured in kilopascals (kps). 3. Tongue strength measured using a digital spoon at baseline (single visit). Measured in gr/cm². 4. Correlation between OMES score and values obtained by IOPI®, Sandway®, and digital spoon, analyzed at baseline (single visit) |
| Overall study start date | 30/01/2025 |
| Completion date | 30/04/2026 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | Cases: 1. Age between 18 and 75 years 2. Diagnosis of moderate to severe OSAHS (AHI >15) with no previous treatment experience 3. No prior treatment for OSAHS 4. Signed informed consent (IC) Controls: 1. Adequate sleep hygiene 2. No complaints of snoring 3. No complaints of daytime sleepiness 4. Epworth Sleepiness Scale < 7 points |
| Key exclusion criteria | 1. Cognitive or neurological deficits 2. Inability to complete questionnaires 3. Severe alcoholism 4. Presence of craniofacial malformations 5. Active neoplastic disease 6. History of orofacial muscle rehabilitation or prior OSA treatment (surgery, MAD, CPAP) |
| Date of first enrolment | 05/05/2025 |
| Date of final enrolment | 05/12/2025 |
Locations
Countries of recruitment
- Spain
Study participating centres
Marbella
29603
Spain
Palmones
11379
Spain
Sponsor information
Hospital/treatment centre
avda severo ochoa 22
Marbella
29603
Spain
| Phone | +34 952774200 |
|---|---|
| fgonzasan@gmail.com | |
| Website | https://www.quironsalud.com/marbella |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 05/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned pulication in a peer-reviewed journal. |
| IPD sharing plan | The dataset generated during and/or analysed during the current study will be available upon request from Dr Eduardo Correa educorreaorl@gmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 06/05/2025 | No | Yes | ||
| Protocol file | 06/05/2025 | No | No |
Additional files
Editorial Notes
06/05/2025: Trial's existence confirmed by Junta de Andalucía.
