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

NCT06776393 | Not Yet Recruiting DMC

• 1 other identifier: APHP240029
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Dysphonia

Keywords

motion mode ultrasound; voice recordings; GRBASI scale; VHI

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  6 months

Secondary Outcomes (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.

  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.

  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.

  6 months

Study Arms (1)

Patients diagnosed with dysphonia following cervical endocrine surgery

OTHER

Prospective single-center cohort study in patients diagnosed with dysphonia following cervical endocrine surgery

Other: ultrasound

Interventions

ultrasound OTHER

"Dynamic translaryngeal Ultrasound Motion mode ultrasound of the laryngeal region during phonation Acoustic recordings VHI questionnaires "

Also known as: voice recordings

Patients diagnosed with dysphonia following cervical endocrine surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Christophe TRESALLET, Pr, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe TRESALLET, Pr, MD, PhD

CONTACT

+33 1 48 95 58 65; christophe.tresallet@aphp.fr

Fréderique FROUIN, PhD

CONTACT

+33 1 69 86 71 97; frederique.frouin@curie.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: patients who have undergone cervical endocrine surgery.

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: January 15, 2025
• Study Start: January 1, 2025
• Primary Completion: June 1, 2025
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 15, 2025

Record last verified: 2024-10