SwallowingLUKENCT07670429
Longitudinal Ultrasound Kinematic Evaluation of Digastric Muscles
An observational study of Swallowing, run by Hopital Forcilles at 1 site in France.
Trial summary
Ultrasound applied to the upper aerodigestive tract for the assessment of swallowing disorders has been the subject of numerous publications in recent years. Changes in the range of motion or muscular characteristics of the structures involved in swallowing are associated with the presence of swallowing disorders. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Swallowing
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2026to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two populations are recruited at Hôpital Forcilles (Férolles-Attilly, France): 1. Healthy volunteers (n=35): Adult staff members (≥18 years) with no history of swallowing disorders or conditions predisposing to dysphagia (neurological/neuromuscular disease, head and neck cancer, prior orotracheal intubation). Recruited on a voluntary basis via institutional communication. 2. Dysphagic patients (n=35): Adults (≥18 years) admitted to short-stay or medical rehabilitation units (diabetology-obesity, pulmonology, oncology, ENT, gastroenterology-nutrition) at Hôpital Forcilles, referred for swallowing evaluation by a speech-language pathologist, affiliated to a social security scheme, and able to provide informed oral consent.
Who may be able to join
- For healthy volunteers:
- Aged 18 years or over
- Verbal, free, informed and express consent from the subject
- For subjects with swallowing disorder
- Subjects admitted to Forcilles Hospital to one of the short-stay or medical care and rehabilitation departments for diabetes and obesity, respiratory medicine, oncology, ENT and gastro-nutrition at Forcilles Hospital;
- Subjects who have undergone an assessment of swallowing disorders by a speech and language therapist;
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- Subjects aged 18 or over at the time of inclusion;
- Enrolment in a social security scheme or eligibility for such a scheme;
- Verbal, free, informed and express consent from the patient.
Who cannot join
- For healthy volunteers :
- Under 18 years of age
- With a history of swallowing disorders
- With a medical history that could cause a swallowing disorder: stay in intensive care with orotracheal intubation; neurological or neuromuscular disease; cancer of the upper aerodigestive tract
- For Subjects with swallowing disorders
- Patients for whom there is no indication for swallowing tests;
Show all 9Show fewer
- Individuals subject to a court-ordered protective measure;
- Patients under guardianship or administration;
- Patients subject to a care restriction order.
Trial locations and contacts
1 site in 1 country.
About this study
Ultrasound applied to the upper aerodigestive tract for the assessment of swallowing disorders has been the subject of numerous publications in recent years. Changes in the range of motion or muscular characteristics of the structures involved in swallowing are associated with the presence of swallowing disorders. However, current assessment remains limited to morphological parameters at rest, whereas the combined analysis of measurements at rest and during contraction is a recognised indicator of muscle activity and recruitment capacity in other areas (diaphragm, pelvic floor).
For the anterior bellies of the digastric muscles, which are central to hyo-laryngeal kinematics during swallowing, the conventional transverse ultrasound approach yields a non-interpretability rate of approximately 30% at rest and exceeding 50% during dynamic assessment, along with insufficient reproducibility. These limitations prevent reliable access to functional muscle parameters such as thickness variation during contraction and pennation angle.
This single-centre, cross-over study aims to evaluate whether a proposed new ultrasound approach (NAEP), based on a longitudinal (sagittal) probe positioning, achieves a significantly higher rate of interpretable measurements compared to the conventional approach. The study enrolls 35 healthy volunteers and 35 patients with dysphagia. Both approaches are applied during the same session for each participant, across four swallowing conditions (dry swallow, 5, 10, and 20 mL water boluses). Secondary objectives include assessment of intra- and inter-rater reliability of the NAEP, analysis of the impact of bolus volume on muscle contraction and hyoid movement, and comparison of morphometric parameters between healthy subjects and dysphagic patients.
Read the detailed description
Background and technical information :
Ultrasound assessment of the anterior bellies of the digastric muscles (ABDM) has historically relied on a transverse (cross-sectional) approach placing the probe in the submental region. This conventional approach (CA) yields a non-interpretability rate of approximately 30% at rest and exceeding 50% during dynamic swallowing assessment, with poor reproducibility, preventing reliable access to functional muscle parameters such as thickness variation during contraction or pennation angle.
The proposed new ultrasound approach (NAEP) involves repositioning the probe to obtain a longitudinal (sagittal) section of the ABDM by rotating the probe 90° from the cross-sectional plane and applying a lateral displacement to align the muscle fibres along their axis. This approach is hypothesised to improve image interpretability and provide access to the pennation angle, a parameter not measurable with the CA.
All examinations are performed using a Sonoscape Expert 2 ultrasound scanner (7-10 MHz high-frequency linear probe), with the participant seated.
Study procedures Healthy volunteers: Each participant undergoes a single-session ultrasound assessment (≤45 minutes total) including image acquisition during four swallowing conditions - dry swallow and 5, 10, and 20 mL water boluses - in a randomised order (block randomisation, n=4). Both the NAEP and CA are applied to each condition, with the order of approaches also randomised at the subject level. Each bolus volume is assessed once per approach.
To assess reproducibility, a second complete examination is performed by a second independent operator (inter-rater reliability) and repeated by the first operator (intra-rater reliability), each separated by a standardised 5-minute interval.
Subjects with dysphagia: Ultrasound acquisition (NAEP and CA) is performed simultaneously during the clinically-indicated Volume-Viscosity Swallow Test (V-VST), following the standard V-VST volume sequence (non-randomised). No additional bolus volumes are administered beyond those clinically validated during the V-VST. The examination may be interrupted at any time based on clinical signs (coughing, wet voice, desaturation). The number of volumes assessed may therefore vary across subjects and will be systematically documented. Ultrasound image analysis is conducted offline, after the clinical assessment.
Parameters recorded
For each swallowing condition and each approach:
ABDM thickness at rest and during contraction (mm) Hyoid bone cranio-caudal displacement (mm) Pennation angle of the ABDM (NAEP only, when obtainable) An image is classified as interpretable if both superficial and deep muscular fasciae of the ABDM are identifiable over ≥50% of the visualised muscle length and allow reliable caliper placement for thickness measurement at rest and during contraction.
Blinded independent review All images are reviewed by a third independent assessor blinded to the primary operator's classifications, to assess inter-rater agreement on interpretability (Cohen's Kappa coefficient) and to conduct a pre-specified sensitivity analysis of the primary endpoint.
Statistical analysis The primary analysis uses a mixed-effects logistic regression model with feasibility (interpretable: yes/no, per swallow) as the dependent variable, approach (NAEP vs. CA), bolus volume, group (healthy/dysphagic), and order of administration as fixed effects, and a random subject intercept to account for repeated measures. The primary result is the odds ratio for the NAEP effect with 95% CI.
A supplementary analysis applies McNemar's test on subject-level overall feasibility (threshold: ≥75% interpretable swallows).
Secondary analyses include: ICC (two-way mixed model) for intra- and inter-rater reliability; linear mixed-effects models for the impact of bolus volume on ABDM thickness variation (Δ%) and hyoid displacement; Pearson/Spearman correlations between muscle parameters and hyoid movement; and between-group comparisons (healthy vs. dysphagic) using t-tests or Mann-Whitney tests with adjusted regression models.
The significance threshold is set at α=0.05 (two-sided) for the primary objective and α=0.01 for confirmatory secondary objectives.
- Conditions
- Swallowing
- Keywords
- Swallowing disorders, Ultrasonography
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Adults without history of swallowing disorders, recruited voluntarily among hospital staff. Each participant undergoes ultrasound assessment of the anterior bellies of the digastric muscles using both the NAEP and the conventional approach, during four swallowing conditions (dry swallow, 5, 10, and 20 mL), in a randomised order. Reproducibility assessment (intra- and inter-rater) is performed in this group only. | |
| Subjects with dysphagia | Hospitalised subjects with a clinically indicated swallowing assessment. Ultrasound acquisition (NAEP and conventional approach) is performed simultaneously during the standard Volume-Viscosity Swallow Test (V-VST). No additional bolus volumes are administered beyond those clinically validated during the V-VST. The number of volumes assessed may vary according to clinical tolerance and is systematically documented. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to evaluate the rate of interpretable ultrasound measurements (feasibility) of the anterior bellies of the digastric muscles obtained using a new ultrasound approach employing a longitudinal section
For each swallowing condition (dry swallow, 5 mL, 10 mL, and 20 mL water bolus), an ultrasound image is classified as interpretable if both superficial and deep muscular fasciae of the anterior belly of the digastric muscle are identifiable over at least 50% of the visualised muscle length, allowing reliable caliper placement for thickness measurement at rest and during contraction. Images not meeting these criteria are classified as non-interpretable. The feasibility rate is expressed as the proportion of interpretable images per swallow (with 95% CI) for each approach (NAEP and conventional approach), and compared using a mixed-effects logistic regression model adjusted for bolus volume, group, and order of administration. A higher proportion indicates better feasibility.
Measured: Day 1
Secondary outcomes (7)
Intraclass Correlation Coefficient (ICC) for NAEP measurements of anterior belly of digastric muscle thickness
Relative reliability of ultrasound thickness measurements of the anterior bellies of the digastric muscles obtained using the NAEP, assessed at rest and during contraction. Intra-rater reliability is evaluated by repeating the full examination twice by the same operator, separated by a 5-minute interval. Inter-rater reliability is assessed by two independent operators performing the examination successively, also separated by a 5-minute interval. Results are expressed as ICC (two-way mixed model) with 95% CI. ICC ≥ 0.75 is considered good reliability.
Measured: Day 1
Change in anterior belly of digastric muscle thickness according to swallowed bolus volume
The relative change in muscle thickness (Δ thickness) is calculated for each swallowing condition as: [(thickness during contraction - thickness at rest) / thickness at rest] × 100. The impact of bolus volume (dry swallow, 5 mL, 10 mL, 20 mL) on Δ thickness is analysed using a linear mixed-effects model with random subject intercept, adjusted for sex, height, and BMI. Post-hoc comparisons between consecutive volumes are performed with Bonferroni correction. A linear trend test assesses the dose-response relationship.
Measured: Day 1
Hyoid bone displacement according to swallowed bolus volume
Hyoid bone movement is defined as the maximum displacement (mm) from rest to peak position during swallowing, measured by ultrasound for each bolus condition (dry swallow, 5 mL, 10 mL, 20 mL). The impact of bolus volume is analysed using a linear mixed-effects model with random subject intercept, adjusted for sex, height, and BMI, with post-hoc Bonferroni-corrected comparisons between consecutive volumes.
Measured: Day 1
Rate of interpretable images for pennation angle measurement of the anterior bellies of the digastric muscles using the NAEP
The pennation angle of the anterior bellies of the digastric muscles is only measurable using the NAEP (longitudinal approach) and is not applicable with the conventional transverse approach. Feasibility is defined as the proportion of swallowing conditions yielding an image of sufficient quality to allow reliable measurement of the pennation angle. Results are expressed as a proportion with 95% CI.
Measured: Day 1
Correlation between change in anterior belly of digastric muscle thickness and hyoid bone displacement during swallowing
The association between relative change in ABDM thickness (Δ thickness, %) and cranio-caudal hyoid bone displacement (mm) is analysed using a linear mixed-effects model with random subject intercept, adjusted for bolus volume and ultrasound approach. The regression coefficient β quantifies the increase in hyoid movement per 1% increase in Δ thickness. An interaction term (Δ thickness × volume) tests whether this relationship varies across bolus volumes.
Measured: Day 1
Correlation between change in pennation angle of the anterior bellies of the digastric muscles and hyoid bone displacement during swallowing
The association between variation in the ABDM pennation angle between rest and contraction during swallowing and cranio-caudal hyoid bone displacement (mm) is analysed using a linear mixed-effects model with random subject intercept, adjusted for bolus volume. This analysis is performed exclusively for NAEP measurements and is conditional on a pennation angle feasibility rate of ≥70%.
Measured: Day 1
Comparison of ultrasound morphometric parameters of the anterior bellies of the digastric muscles between healthy volunteers and patients with dysphagia
The following parameters are compared between the two groups for swallowing conditions common to both populations (dry swallow and 5 mL): rate of interpretable images per approach, resting ABDM thickness (mm), relative change in ABDM thickness during contraction (Δ%), and cranio-caudal hyoid bone displacement (mm). Between-group comparisons use Student's t-test or Mann-Whitney test depending on normality (Shapiro-Wilk), with effect sizes (Cohen's d or rank r) and 95% CI. Adjusted regression models control for age, sex, and BMI. Given the sample size of the dysphagia group (n=35) and the exploratory nature of this analysis, results are interpreted as hypothesis-generating.
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 posted26 Jun 2026
- Study start4 May 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SwallowingStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Forcilles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Díaz López, PhD (c), Principal investigator, Hôpital Forcilles Fondation Cognacq-Jay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670429
- Sponsor's protocol ID
- 2026-A00416-45
- Acronym
- LUKE
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Ultrasound Kinematic Evaluation of Digastric Muscles
- ClinicalTrials.gov ID
- NCT07670429
- Acronym / sponsor ID
- LUKE / 2026-A00416-45
- Conditions
- Swallowing
- Keywords
- Swallowing disorders, Ultrasonography
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hopital ForcillesUniversity, hospital or other
- Study start
- 4 May 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 26 Jun 2026 (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.
Ultrasound applied to the upper aerodigestive tract for the assessment of swallowing disorders has been the subject of numerous publications in recent years. Changes in the range of motion or muscular characteristics of the structures involved in swallowing are associated with the presence of swallowing disorders. However, current assessment remains limited to morphological parameters at rest, whereas the combined analysis of measurements at rest and during contraction is a recognised indicator of muscle activity and recruitment capacity in other areas (diaphragm, pelvic floor).
For the anterior bellies of the digastric muscles, which are central to hyo-laryngeal kinematics during swallowing, the conventional transverse ultrasound approach yields a non-interpretability rate of approximately 30% at rest and exceeding 50% during dynamic assessment, along with insufficient reproducibility. These limitations prevent reliable access to functional muscle parameters such as thickness variation during contraction and pennation angle.
This single-centre, cross-over study aims to evaluate whether a proposed new ultrasound approach (NAEP), based on a longitudinal (sagittal) probe positioning, achieves a significantly higher rate of interpretable measurements compared to the conventional approach. The study enrolls 35 healthy volunteers and 35 patients with dysphagia. Both approaches are applied during the same session for each participant, across four swallowing conditions (dry swallow, 5, 10, and 20 mL water boluses). Secondary objectives include assessment of intra- and inter-rater reliability of the NAEP, analysis of the impact of bolus volume on muscle contraction and hyoid movement, and comparison of morphometric parameters between healthy subjects and dysphagic patients.
Detailed description
Background and technical information :
Ultrasound assessment of the anterior bellies of the digastric muscles (ABDM) has historically relied on a transverse (cross-sectional) approach placing the probe in the submental region. This conventional approach (CA) yields a non-interpretability rate of approximately 30% at rest and exceeding 50% during dynamic swallowing assessment, with poor reproducibility, preventing reliable access to functional muscle parameters such as thickness variation during contraction or pennation angle.
The proposed new ultrasound approach (NAEP) involves repositioning the probe to obtain a longitudinal (sagittal) section of the ABDM by rotating the probe 90° from the cross-sectional plane and applying a lateral displacement to align the muscle fibres along their axis. This approach is hypothesised to improve image interpretability and provide access to the pennation angle, a parameter not measurable with the CA.
All examinations are performed using a Sonoscape Expert 2 ultrasound scanner (7-10 MHz high-frequency linear probe), with the participant seated.
Study procedures Healthy volunteers: Each participant undergoes a single-session ultrasound assessment (≤45 minutes total) including image acquisition during four swallowing conditions - dry swallow and 5, 10, and 20 mL water boluses - in a randomised order (block randomisation, n=4). Both the NAEP and CA are applied to each condition, with the order of approaches also randomised at the subject level. Each bolus volume is assessed once per approach.
To assess reproducibility, a second complete examination is performed by a second independent operator (inter-rater reliability) and repeated by the first operator (intra-rater reliability), each separated by a standardised 5-minute interval.
Subjects with dysphagia: Ultrasound acquisition (NAEP and CA) is performed simultaneously during the clinically-indicated Volume-Viscosity Swallow Test (V-VST), following the standard V-VST volume sequence (non-randomised). No additional bolus volumes are administered beyond those clinically validated during the V-VST. The examination may be interrupted at any time based on clinical signs (coughing, wet voice, desaturation). The number of volumes assessed may therefore vary across subjects and will be systematically documented. Ultrasound image analysis is conducted offline, after the clinical assessment.
Parameters recorded
For each swallowing condition and each approach:
ABDM thickness at rest and during contraction (mm) Hyoid bone cranio-caudal displacement (mm) Pennation angle of the ABDM (NAEP only, when obtainable) An image is classified as interpretable if both superficial and deep muscular fasciae of the ABDM are identifiable over ≥50% of the visualised muscle length and allow reliable caliper placement for thickness measurement at rest and during contraction.
Blinded independent review All images are reviewed by a third independent assessor blinded to the primary operator's classifications, to assess inter-rater agreement on interpretability (Cohen's Kappa coefficient) and to conduct a pre-specified sensitivity analysis of the primary endpoint.
Statistical analysis The primary analysis uses a mixed-effects logistic regression model with feasibility (interpretable: yes/no, per swallow) as the dependent variable, approach (NAEP vs. CA), bolus volume, group (healthy/dysphagic), and order of administration as fixed effects, and a random subject intercept to account for repeated measures. The primary result is the odds ratio for the NAEP effect with 95% CI.
A supplementary analysis applies McNemar's test on subject-level overall feasibility (threshold: ≥75% interpretable swallows).
Secondary analyses include: ICC (two-way mixed model) for intra- and inter-rater reliability; linear mixed-effects models for the impact of bolus volume on ABDM thickness variation (Δ%) and hyoid displacement; Pearson/Spearman correlations between muscle parameters and hyoid movement; and between-group comparisons (healthy vs. dysphagic) using t-tests or Mann-Whitney tests with adjusted regression models.
The significance threshold is set at α=0.05 (two-sided) for the primary objective and α=0.01 for confirmatory secondary objectives.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | –Adults without history of swallowing disorders, recruited voluntarily among hospital staff. Each participant undergoes ultrasound assessment of the anterior bellies of the digastric muscles using both the NAEP and the conventional approach, during four swallowing conditions (dry swallow, 5, 10, and 20 mL), in a randomised order. Reproducibility assessment (intra- and inter-rater) is performed in this group only. |
| Subjects with dysphagia | – | –Hospitalised subjects with a clinically indicated swallowing assessment. Ultrasound acquisition (NAEP and conventional approach) is performed simultaneously during the standard Volume-Viscosity Swallow Test (V-VST). No additional bolus volumes are administered beyond those clinically validated during the V-VST. The number of volumes assessed may vary according to clinical tolerance and is systematically documented. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two populations are recruited at Hôpital Forcilles (Férolles-Attilly, France): 1. Healthy volunteers (n=35): Adult staff members (≥18 years) with no history of swallowing disorders or conditions predisposing to dysphagia (neurological/neuromuscular disease, head and neck cancer, prior orotracheal intubation). Recruited on a voluntary basis via institutional communication. 2. Dysphagic patients (n=35): Adults (≥18 years) admitted to short-stay or medical rehabilitation units (diabetology-obesity, pulmonology, oncology, ENT, gastroenterology-nutrition) at Hôpital Forcilles, referred for swallowing evaluation by a speech-language pathologist, affiliated to a social security scheme, and able to provide informed oral consent.
Key inclusion criteria (9 listed)
- For healthy volunteers:
- For subjects with swallowing disorder
Key exclusion criteria (9 listed)
- For healthy volunteers :
- For Subjects with swallowing disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary objective of this study is to evaluate the rate of interpretable ultrasound measurements (feasibility) of the anterior bellies of the digastric muscles obtained using a new ultrasound approach employing a longitudinal section
Time frame: Day 1
For each swallowing condition (dry swallow, 5 mL, 10 mL, and 20 mL water bolus), an ultrasound image is classified as interpretable if both superficial and deep muscular fasciae of the anterior belly of the digastric muscle are identifiable over at least 50% of the visualised muscle length, allowing reliable caliper placement for thickness measurement at rest and during contraction. Images not meeting these criteria are classified as non-interpretable. The feasibility rate is expressed as the proportion of interpretable images per swallow (with 95% CI) for each approach (NAEP and conventional approach), and compared using a mixed-effects logistic regression model adjusted for bolus volume, group, and order of administration. A higher proportion indicates better feasibility.
7 secondary outcomes
Intraclass Correlation Coefficient (ICC) for NAEP measurements of anterior belly of digastric muscle thickness
Time frame: Day 1
Change in anterior belly of digastric muscle thickness according to swallowed bolus volume
Time frame: Day 1
Hyoid bone displacement according to swallowed bolus volume
Time frame: Day 1
Rate of interpretable images for pennation angle measurement of the anterior bellies of the digastric muscles using the NAEP
Time frame: Day 1
Correlation between change in anterior belly of digastric muscle thickness and hyoid bone displacement during swallowing
Time frame: Day 1
Correlation between change in pennation angle of the anterior bellies of the digastric muscles and hyoid bone displacement during swallowing
Time frame: Day 1
Comparison of ultrasound morphometric parameters of the anterior bellies of the digastric muscles between healthy volunteers and patients with dysphagia
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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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.
Carlos Díaz López, PhD (c) principal investigator
Hôpital Forcilles Fondation Cognacq-Jay
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 Swallowing, run by Hopital Forcilles at 1 site in France.
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 9 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 23 Sep 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 France. 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?
This study is still under way. Results are not available in the source record yet.
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?
The primary objective of this study is to evaluate the rate of interpretable ultrasound measurements (feasibility) of the anterior bellies of the digastric muscles obtained using a new ultrasound approach employing a longitudinal section (time frame: Day 1). 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 23 Sep 2026.