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HealthyNCT07024069

Protocol for Tongue Elastography and Ultrasound Markers

An observational study of Healthy and Healthy Individuals (Controls), run by Haute Ecole Bruxelles-Brabant at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this observational is to methodologically assess the standardisation and reliability of a protocol of ultrasound lingual markers, including tongue shear-wave elastography, attenuation indexes, and echo intensity in adult healthy subjects. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Healthy Individuals (Controls)
What is being tested?
Tongue ultrasound via submental approach
How many people
55 participants
Where
1 siteBelgium
Study dates
5 Sep 2024to 1 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Healthy subjects (aged 18-45), male and female, recruited from physiotherapy students at ISEK-HE2B and health students at VUB (Brussels Health Campus site in 1090 Jette) and their relatives.

Who may be able to join

  • Healthy adults aged 18-45 years
  • Able to understand and provide informed consent

Who cannot join

  • Any orthopaedic, traumatic, or rheumatic conditions affecting the head or neck
  • Presence of metabolic disorders (e.g., diabetes, metabolic syndrome)
  • Presence of cardiovascular conditions
  • Diagnosed sleep disorders or known sleep apnea syndrome, as evaluated by the Stop-Bang and Berlin questionnaires
  • Consumption of alcohol or drugs within 48 hours prior to the experiment

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Isek He2B

    Brussels, 1160

Other trials in Belgium

About this study

Official title: Tongue Shear-wave Elastography and Attenuation Ultrasound Markers in Healthy Subjects: a Protocol Study

The purpose of this observational is to methodologically assess the standardisation and reliability of a protocol of ultrasound lingual markers, including tongue shear-wave elastography, attenuation indexes, and echo intensity in adult healthy subjects.

The main goals are to create a standardized protocol and its intra- et inter-rater reliability, in order to gather some data in a non-pathological population. This protocol will be used in further studies in the context of tongue fat accumulation, such as in obstructive sleep apnea syndrome.

Participants will be lying in supine position and after basic descriptive data collection (height, weight, neck circumference), submental ultrasound will be performed on them. This procedure is non-invasive, painless, safe (ultrasound does not involve ionising radiation) for the healthy participants.

Read the detailed description

Scientific literature is reporting increasing evidence that fat accumulation in the tongue and oropharyngeal region is linked to cardiovascular disorders in people with obesity. In this context, fat accumulation on the tongue is a contributing factor to Obstructive Sleep Apnea syndrome (OSA). The presence of OSA is a significant risk factor for the development of cardiovascular disease and is directly correlated with overall adiposity, while the percentage of neck fat relative to the abdomen is correlated with the severity of OSA in obese individuals, highlighting the relevance of studying body fat distribution. The links between increased tongue size, neck and oropharyngeal adiposity, BMI, and sleep-disordered breathing have been supported by magnetic resonance imaging (MRI) and cone beam computed tomography studies and are now well documented. It is interesting to note that OSA also affects people who are not obese, highlighting the relevance of studying its risk factors. Excessive lipid accumulation in peripheral tissues therefore appears to be a key feature of many metabolic diseases. Thus, early detection of excessive lipid accumulation in tissues and therapeutic monitoring are key to prevention and individualised, patient-centred care. Ultrasound has recently been used to establish a link between oropharyngeal fat and OSA: studies showed that changes in the dynamic properties of the tongue muscles measured by elastography, or the size and volume of the tongue, could be a biomarker for screening for OSA in adults. Shear wave elastography (SWE) is already used for fat accumulation in various organs, for example in liver or kidney diseases, and some authors have begun to work on the musculoskeletal system. This technique uses acoustic force to generate shear waves (which can propagate perpendicular to the ultrasound beam, causing transient tissue deformation that can be measured by the machine's module), providing a measure of the elastic properties of the tissue, which is reported as 'rigidity' or 'stiffness'. When muscles are infiltrated by lipid deposits, the histological content changes, leading to a modification of tissue properties. This ultrasound approach is a simple, non-irradiating and harmless technique that could be applied in the future therapeutic follow-up of patients with OSA.

Moreover, it is important to underscore that the lingual ultrasound markers analysed in this study are not solely indicative of fat content within the tongue. They are also likely to depict biomechanical characteristics of tongue tissues. Indeed, these markers can be influenced by various compositional and structural changes, including modifications in fat content, connective or fibrous tissue density, presence of edema or swelling... As such, variations in ultrasound-derived parameters may determine a range of tissue properties beyond adiposity, providing a more comprehensive insight into the biomechanical state of the tongue that is particularly involved in obstructive sleep apnea. This lingual ultrasound protocol could then be use in further studies by applying it in patients suffering from OSA.

Study objectives: The main objective of this study is to investigate ultrasound markers of fat accumulation in the tongue in healthy individuals, to assess the reliability and repeatability of the measurement, and to determine the distribution of tongue fat values in different regions of the tongue. The secondary objective will be to study the correlations of these values with the subjects' basic anthropometric data. The aim of obtaining values in healthy subjects will be to compare them with a future study on a population suffering from OSA.

Being tested
Tongue ultrasound via submental approach
Keywords
tongue ultrasound, submental ultrasound, tongue stiffness, echo intensity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tongue ultrasound via submental approachOther

    Also called Weight, height, neck circumference

    Descriptive and anthropometric data will be recorded for each participant, including age, sex, weight (kg), height (m), neck circumferences (cm). Body mass index (expressed in kg/m2) will be calculated.

    Submental ultrasound (US) images of the tongue will be performed on a patient lying supine, using a 5-15 MHz convex transducer. The parameters will be identical for all subjects and set at a depth of 9 cm, a focus of 4 cm and a gain of 45%. Each measurement will be taken thrice by a trained operator; the mean and standard deviation being used for analysis.

Study groups in NCT07024069
Study groupRoleWhat they receive
Healthy adult subjectsHealthy subjects (aged 18-45), male and female. All subjects will give their informed consent. Consequently, exclusion criteria will include any orthopaedic, traumatological or rheumatic pathology of the cervico-cephalic extremities, as well as any metabolic (diabetes, metabolic syndrome, etc.) or cardiovascular pathology. In particular, subjects must not suffer from sleep disorders or OSA, as identified by the Berlin Sleep Questionnaire and Stop-BANG questionnaire. Subjects will be asked not to consume alcohol or drugs 48 hours before the experiment.
Receives: Other: Tongue ultrasound via submental approach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tongue stiffness (ultrasound)

    Tongue stiffness (in kPa), measured with shear-wave elastography (ultrasound submental approach)

    Measured: Day 1

  2. Tongue Echo Intensity (ultrasound)

    Tongue Echo Intensity, expressed as the mean value of pixels in a 0-255 gray scale (ultrasound submental approach)

    Measured: Day 1

  3. Tongue Tissue Attenuation Imaging (ultrasound)

    Tongue Tissue Attenuation Imaging, measured with ultrasound submental approach, reflecting the quantitative measurement of US attenuation in tissue in dB/cm/MHz

    Measured: Day 1

  4. Tongue thickness (ultrasound)

    Tongue thickness (in cm, measured via ultrasound submental approach), reflects its size, representing the vertical distance between its most superior surface point to its most inferior

    Measured: Day 1

Secondary outcomes (5)
  1. Age

    Age (in years) will be collected via a questionnaire

    Measured: Day 1

  2. Weight

    Weight (in kg) will be measured with a weighing scale

    Measured: Day 1

  3. Height

    Height (in m) will be collected with a stadiometer

    Measured: Day 1

  4. Neck circumference

    Neck circumference (in cm) will be measured with a lufkin tape according to the International Society for the Advancement of Kinanthropometry (ISAK) guidelines.

    Measured: Day 1

  5. Body Mass Index (BMI)

    Weight and height will be combined to report BMI in kg/m^2

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2025
  2. Study start5 Sep 2024
  3. Primary completion1 Apr 2025
  4. Study completion1 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07024069
Sponsor's protocol ID
B200-2024-057
Status last verified
Dec 2025
First submitted
28 May 2025
Last updated
5 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy and Healthy Individuals (Controls), run by Haute Ecole Bruxelles-Brabant at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tongue stiffness (ultrasound) (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.

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