Longitudinal Non-invasive Analysis of VOCAle Cord Function Based on Trans-laryngeal Ultrasound Acquisitions and Voice Recordings
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ultrasound.
- Who it may be relevant to
- Registry conditions: Postoperative Dysphonia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The main objective of VOCALISE study is to propose a new approach allowing a better characterization of postoperative dysphonia. This involves associating with dynamic translaryngeal ultrasound optimized acquisitions of the vibration of each vocal fold in phonation simultaneously with voice recordings. A software program to analyze the displacement of arytenoids, markers of substitution of the vocal cords, will be developed to finely quantify the mobility of laryngeal structures, by combining classical methods of motion analysis and deep learning methods. This approach will be evaluated to follow speech therapy rehabilitation in patients with post-operative dysphonia following recurrent nerve injury.
Detailed description
Dynamic translaryngeal ultrasound (dTLUS), a non-invasive and inexpensive technique, has emerged in recent years as an alternative to nasofibroscopy for assessing vocal cord paralysis. This paralysis is the major risk (3 to 5%) associated with cervical surgery (100,000 procedures per year in France). Initial work by our consortium has demonstrated the performance of dTLUS after thyroid or parathyroid surgery in the early diagnosis of vocal cord paralysis. The aim of VOCALISE is to propose a new approach for better characterisation of post-operative dysphonia. This involves combining optimised dTLUS acquisitions with acquisitions of the vibration of each vocal cord during phonation, simultaneously with voice recordings. Software will be developed to analyse the displacement of the arytenoids, which are surrogate markers for the vocal cords, in order to quantify the mobility of laryngeal structures in fine detail, using a combination of conventional motion analysis methods and deep learning methods.
This approach will be evaluated to monitor speech therapy rehabilitation in patients with post-operative dysphonia following a lesion of the recurrent nerve.
Interventions
- Other ultrasound
"Dynamic translaryngeal Ultrasound Motion mode ultrasound of the laryngeal region during phonation Acoustic recordings VHI questionnaires "
Primary outcome measures
- To evaluate the contribution of translaryngeal ultrasound combined with acoustic and perceptual measurements of voice and speech classically used in speech therapy for the rehabilitation of patients with dysphonia following surgery. [Time frame: 6 months]
Secondary outcome measures (3)
- To visualise arytenoid motion in subjects with shadow artifact using the standard dTLUS approach, by optimising dTLUS acquisitions including curvilinear probe acquisitions, gel cushion acquisitions and lateral mode acquisitions. [Time frame: 6 months]
- To visualise arytenoid motion in subjects with shadow artifact using the standard dTLUS approach, by optimising dTLUS acquisitions including curvilinear probe acquisitions, gel cushion acquisitions and lateral mode acquisitions. [Time frame: 6 months]
- To visualise arytenoid motion in subjects with shadow artifact using the standard dTLUS approach, by optimising dTLUS acquisitions including curvilinear probe acquisitions, gel cushion acquisitions and lateral mode acquisitions. [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Patient over 18 years of age
- Obtaining patient's free and informed consent
- Patients with dysphonia following cervical surgery and referred for speech therapy
- Social security scheme membership (beneficiary or entitled), excluding MA
Exclusion criteria
- Known preoperative history of recurrent nerve paralysis (PR)
- History of laryngeal or vocal cord tumour
- Surgical complications preventing proper assessment of postoperative vocal cord mobility (tracheotomy, tracheal resection).
- Patients with a history of thyroid or parathyroid surgery or cervicotomy for another pathology
- Patient under guardianship or guardianship or deprived of liberty or under safeguard of justice
- Pregnant or nursing patient
- Patient does not read or has vision problems
- Cognitive and/or auditory impairment preventing
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06776393 · APHP240029