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Active Not Recruiting NCT07670429

Longitudinal Ultrasound Kinematic Evaluation of Digastric Muscles

Conditions: Swallowing

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 70
Sponsor: Hopital Forcilles

Location: Hôpital Forcilles Férolles-Attilly Île-de-France Region

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.

Eligibility Criteria

Inclusion Criteria: * For healthy volunteers: 1. Aged 18 years or over 2. Verbal, free, informed and express consent from the subject * For subjects with swallowing disorder 1. 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; 2. Subjects who have undergone an assessment of swallowing disorders by a speech and language therapist; 3. Subjects aged 18 or over at the time of inclusion; 4. Enrolment in a social security scheme or eligibility for such a scheme; 5. Verbal, free, informed and express consent from the patient. Exclusion Criteria: * For healthy volunteers : 1. Under 18 years of age 2. With a history of swallowing disorders 3. 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 1. Patients for whom there is no indication for swallowing tests; 2. Individuals subject to a court-ordered protective measure; 3. Patients under guardianship or administration; 4. Patients subject to a care restriction order.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07670429). StuddyBuddy aggregates publicly available trial information.