Measuring muscle function in patients with obstructive sleep apnea
| ISRCTN | ISRCTN58267316 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58267316 |
| Secondary identifying numbers | 21/65 |
- Submission date
- 02/11/2024
- Registration date
- 14/11/2024
- Last edited
- 13/11/2024
- 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 (OSA) is a condition where the walls of the throat relax and narrow or close during sleep. Myofunctional therapy (MT) is a recent treatment option for OSA that involves orofacial (mouth and face) muscle training. However, few OSA guidelines include myofunctional assessment routinely during the examination at the Ear, Nose & Thorat (ENT) office. This study aims to present the researchers' protocol for the examination of OSA adult patients, with a special interest in myofunctional evaluation.
Who can participate?
Patients aged 18 years and over who are scheduled for septoplasty (surgery to straighten the nasal septum) to screen for OSA
What does the study involve?
Once the routine ENT exam is done, the myofunctional exam includes measurements of lip sealing (how lips are closed during breathing), the lingual frenulum (tongue-tie that limits tongue movements), and the strength of the tongue and mouth muscles.
What are the possible benefits and risks of participating?
The main benefits for participants will be to receive an OSA diagnosis and myofunctional treatment. Few risks are expected, only related to a longer exam during the ENT consultation.
Where is the study run from?
Hospital Universitario de Fuenlabrada (Spain)
When is the study starting and how long is it expected to run for?
September 2021 to May 2025
Who is funding the study?
Hospital Universitario de Fuenlabrada (Spain)
Who is the main contact?
Prof. Guillermo Plaza, guillermo.plaza@salud.madrid.org
Contact information
Public, Scientific, Principal Investigator
Camino del Molino, 2
Fuenlabrada
28005
Spain
 ORCID ID |
0000-0001-6409-4921 |
|---|---|
| Phone | +34 (0)679472218 |
| guillermo.plaza@salud.madrid.org |
Study information
| Study design | Prospective non-randomized study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic, Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Myofunctional evaluation as a part of the diagnosis of obstructive sleep apnea |
| Study acronym | MF-OSA |
| Study objectives | Myofunctional therapy is a recent treatment option for obstructive sleep apnea (OSA). Examination of OSA adult patients should include myofunctional evaluation. |
| Ethics approval(s) |
Approved 14/12/2021, Hospital Universitario de Fuenlabrada Ethics Committee (Camino del Molino, 2, Fuenlabrada, 28042, Spain; +34 (0)916006600; ceic.hflr@salud.madrid.org), ref: 21/65 |
| Health condition(s) or problem(s) studied | Obstructive sleep apnea (OSA) |
| Intervention | ENT office exam, polysomnography and myofunctional evaluation including breathing type, lip sealing, lingual frenulum and evaluation of muscle strength of the lingual and oral muscles with the IOPI. |
| Intervention type | Other |
| Primary outcome measure | Polysomnography assessed with the Apnea-Hypopnea Index (AHI), with mild OSA defined as >5 events/h of sleep, moderate OSA as 15–29.9 events/h of sleep, and severe OSA as ≥30 events/h of sleep at one timepoint |
| Secondary outcome measures | The following secondary outcome measures are assessed at one timepoint: 1. Anatomical findings in the upper airway from the nasal valve area to the larynx: 1.1. Friedman tonsil grading, scaled from 1 to 5 1.2. Height of the hard palate, measured in centimeters 1.3. Friedman tongue position (FTP), scaled from 1 to 5 1.4. Mallampati scales, scaled from 1 to 5 1.5. Basilingual hypertrophy assessed with lingual tonsil hypertrophy (LTH) Friedman classification, scaled from 1 to 5 1.6. Awake dynamic exam with Müller maneuver, considered collapsed or not 2. Myofunctional exam: 2.1. Breathing (nasal or oral) 2.2. Lingual sealing (opened or closed) 2.3. Lingual frenulum assessed using the Marchesani protocol (present or not) 2.4. Muscle strength evaluated with the Iowa Oral Performance Instrument (IOPI) in KiloPascals at buccinator and tongue propulsion |
| Overall study start date | 05/09/2021 |
| Completion date | 05/05/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 90 |
| Key inclusion criteria | Adult patients scheduled for septoplasty evaluated to screen for OSA at the Otorhinolaryngology Department |
| Key exclusion criteria | 1. Systemic disease with a known inflammatory state 2. Presence of a muscle rehabilitation treatment 3. Previous nasal surgery 4. Previous OSA treatment (CPAP, surgery, or mandibular advancement device) |
| Date of first enrolment | 05/11/2023 |
| Date of final enrolment | 05/12/2024 |
Locations
Countries of recruitment
- Spain
Study participating centre
Fuenlabrada
28005
Spain
Sponsor information
Hospital/treatment centre
Camino del Molino, 2
Fuenlabrada
28042
Spain
| Phone | +34 (0)916006186 |
|---|---|
| guillermo.plaza@salud.madrid.org | |
| Website | https://www.comunidad.madrid/hospital/fuenlabrada/ |
"ROR" |
https://ror.org/04scbtr44 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 05/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Prof. Guillermo Plaza (guillermo.plaza@salud.madrid.org) |
Editorial Notes
13/11/2024: Study's existence confirmed by Hospital Universitario de Fuenlabrada Ethics Committee.
