Measuring muscle function in patients with obstructive sleep apnea

ISRCTN	ISRCTN58267316
DOI	https://doi.org/10.1186/ISRCTN58267316
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	21/65
Sponsor	Hospital Universitario de Fuenlabrada
Funder	Hospital Universitario de Fuenlabrada

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Prof Guillermo Plaza
Public, Scientific, Principal investigator

Camino del Molino, 2
Fuenlabrada
28005
Spain

ORCID ID	0000-0001-6409-4921
Phone	+34 (0)679472218
Email	guillermo.plaza@salud.madrid.org

Study information

Primary study design	Observational
Study design	Prospective non-randomized study
Secondary study design	Cohort study
Study type	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(s)	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
Key secondary outcome measure(s)	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
Completion date	05/05/2025

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	80 Years
Sex	All
Target sample size at registration	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

Hospital universitario de Fuenlabrada

Camino del Molino, 2
Fuenlabrada
28005
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 will be available upon request from Prof. Guillermo Plaza (guillermo.plaza@salud.madrid.org)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

13/11/2024: Study's existence confirmed by Hospital Universitario de Fuenlabrada Ethics Committee.