Protocol for Tongue Elastography and Ultrasound Markers

NCT07024069 | Completed

• 1 other identifier: B200-2024-057
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy; Healthy Individuals (Controls)

Keywords

tongue ultrasound; submental ultrasound; tongue stiffness; echo intensity

Outcome Measures

Primary Outcomes (4)

• Tongue stiffness (ultrasound)

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

  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)

  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

  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

  Day 1

Secondary Outcomes (5)

• Age

  Day 1

• Weight

  Day 1

• Height

  Day 1

• Neck circumference

  Day 1

• Body Mass Index (BMI)

  Day 1

Other Outcomes (2)

• Berlin Sleep Questionnaire

  Day 1

• Stop-Bang Questionnaire

  Day 1

Study Arms (1)

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.

Other: Tongue ultrasound via submental approach

Interventions

Tongue ultrasound via submental approach OTHER

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.

Also known as: Weight, height, neck circumference

Healthy adult subjects

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haute Ecole Bruxelles-Brabant: lead

Study Sites (1)

Isek He2B

Brussels, 1160, Belgium

Location

MeSH Terms

Interventions

Weights and Measures; Body Height

Intervention Hierarchy (Ancestors)

Investigative Techniques; Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Appearance, Body; Anthropometry; Physiological Phenomena; Growth; Growth and Development

Study Officials

• Steven Provyn, PhD

  HE2B & VUB

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MSc PT Drs

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 17, 2025
• Study Start: September 5, 2024
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

BE (1)