Longitudinal Non-invasive Analysis of VOCAle Cord Function Based on Trans-laryngeal Ultrasound Acquisitions and Voice Recordings

Not Applicable

Not yet recruiting

• Conditions: Postoperative Dysphonia

• Registration Number: NCT06776393
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-23
• Study Start: 2025-01
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-06
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	6 months	Correlation of each quantitative evaluation criterion proposed in ultrasound and voice and speech analysis with the classical voice quality criteria: the VHI (voice handicap index), the GRBASI scale (defined by 5 expert speech pathologists) and a set of acoustic measures of voice and speech.

Secondary Outcome Measures

Name	Time	Method
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.	6 months	- Sensitivity and specificity for the prediction of a recovery for each quantitative index proposed before the start of speech therapy on the population tested."