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.
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.
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.
- Conditions
- Healthy, Healthy Individuals (Controls)
- 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 group | Role | What they receive |
|---|---|---|
| Healthy adult subjects | Healthy 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.
Tongue stiffness (ultrasound)
Tongue stiffness (in kPa), measured with shear-wave elastography (ultrasound submental approach)
Measured: Day 1
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
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
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)
Age
Age (in years) will be collected via a questionnaire
Measured: Day 1
Weight
Weight (in kg) will be measured with a weighing scale
Measured: Day 1
Height
Height (in m) will be collected with a stadiometer
Measured: Day 1
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
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.
- First posted17 Jun 2025
- Study start5 Sep 2024
- Primary completion1 Apr 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Haute Ecole Bruxelles-Brabant
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frédéric Paillaugue, Haute Ecole Bruxelles-Brabant
- Investigators
- Steven Provyn, PhD, Study director, HE2B & VUB
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tongue Shear-wave Elastography and Attenuation Ultrasound Markers in Healthy Subjects: a Protocol Study
- ClinicalTrials.gov ID
- NCT07024069
- Acronym / sponsor ID
- B200-2024-057
- Conditions
- Healthy, Healthy Individuals (Controls)
- Keywords
- tongue ultrasound, submental ultrasound, tongue stiffness, echo intensity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Haute Ecole Bruxelles-BrabantUniversity, hospital or other
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adult subjects | – | Other: Tongue ultrasound via submental approachHealthy 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Healthy adults aged 18-45 years
- Able to understand and provide informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tongue ultrasound via submental approachAlso: Weight, height, neck circumferenceDescriptive 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. | Other | Healthy adult subjects |
Primary outcome
Tongue stiffness (ultrasound)
Time frame: Day 1
Tongue stiffness (in kPa), measured with shear-wave elastography (ultrasound submental approach)
Tongue Echo Intensity (ultrasound)
Time frame: Day 1
Tongue Echo Intensity, expressed as the mean value of pixels in a 0-255 gray scale (ultrasound submental approach)
Tongue Tissue Attenuation Imaging (ultrasound)
Time frame: Day 1
Tongue Tissue Attenuation Imaging, measured with ultrasound submental approach, reflecting the quantitative measurement of US attenuation in tissue in dB/cm/MHz
Tongue thickness (ultrasound)
Time frame: Day 1
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
5 secondary outcomes
Age
Time frame: Day 1
Weight
Time frame: Day 1
Height
Time frame: Day 1
Neck circumference
Time frame: Day 1
Body Mass Index (BMI)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Provyn, PhD study director
HE2B & VUB
1 site in 1 country: see every site and its status.
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.