Longitudinal Ultrasound Kinematic Evaluation of Digastric Muscles

NCT07670429 | Active Not Recruiting

• 1 other identifier: 2026-A00416-45
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Swallowing

Keywords

Swallowing disorders; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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.

  During a single experimental session, at the time of ultrasound acquisition

Secondary Outcomes (7)

• Intraclass Correlation Coefficient (ICC) for NAEP measurements of anterior belly of digastric muscle thickness

  During a single experimental session, assessed in healthy volunteers only (two consecutive examinations per operator, separated by 5 minutes). Echographers will be blinded.

• Change in anterior belly of digastric muscle thickness according to swallowed bolus volume

  During a single experimental session, at the time of ultrasound acquisition

• Hyoid bone displacement according to swallowed bolus volume

  During a single experimental session, at the time of ultrasound acquisition

• Rate of interpretable images for pennation angle measurement of the anterior bellies of the digastric muscles using the NAEP

  During a single experimental session, at the time of ultrasound acquisition

• Correlation between change in anterior belly of digastric muscle thickness and hyoid bone displacement during swallowing

  During a single experimental session, at the time of ultrasound acquisition

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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;
• Enrolment in a social security scheme or eligibility for such a scheme;
• Verbal, free, informed and express consent from the patient.

You may not qualify if:

• 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;
• Individuals subject to a court-ordered protective measure;
• Patients under guardianship or administration;
• Patients subject to a care restriction order.

Sponsors & Collaborators

• Hopital Forcilles: lead

Study Sites (1)

Hôpital Forcilles

Férolles-Attilly, Île-de-France Region, 77150, France

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Carlos Díaz López, PhD (c)

  Hôpital Forcilles Fondation Cognacq-Jay

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 26, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 26, 2026

Record last verified: 2026-06

Locations

FR (1)