Postoperative DysphoniaVOCALISENCT06776393
Longitudinal Non-invasive Analysis of VOCAle Cord Function Based on Trans-laryngeal Ultrasound Acquisitions and Voice Recordings
A study testing ultrasound in people with Postoperative Dysphonia, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Dysphonia
- What is being tested?
- ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Postoperative Dysphonia
- Being tested
- ultrasound
- Keywords
- motion mode ultrasound, voice recordings, GRBASI scale, VHI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundOther
Also called voice recordings
"Dynamic translaryngeal Ultrasound Motion mode ultrasound of the laryngeal region during phonation Acoustic recordings VHI questionnaires "
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with dysphonia following cervical endocrine surgery | Other | Prospective single-center cohort study in patients diagnosed with dysphonia following cervical endocrine surgery Receives: Other: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
- Correlation between spectral measurements made with ultrasound in motion mode with spectral measurements obtained from voice recording.
Measured: 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.
- Comparison of spectral measurements made in M mode on the left and right sides in two groups of patients: those with impaired mobility of laryngeal structures on ultrasound, those without impaired mobility.
Measured: 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.
- Sensitivity and specificity for the prediction of a recovery for each quantitative index proposed before the start of speech therapy on the population tested."
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DysphoniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- patients who have undergone cervical endocrine surgery.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe TRESALLET, Pr, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776393
- Sponsor's protocol ID
- APHP240029
- Acronym
- VOCALISE
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Non-invasive Analysis of VOCAle Cord Function Based on Trans-laryngeal Ultrasound Acquisitions and Voice Recordings
- ClinicalTrials.gov ID
- NCT06776393
- Acronym / sponsor ID
- VOCALISE / APHP240029
- Conditions
- Postoperative Dysphonia
- Keywords
- motion mode ultrasound, voice recordings, GRBASI scale, VHI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients who have undergone cervical endocrine surgery.
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with dysphonia following cervical endocrine surgery | Other | Other: ultrasoundProspective single-center cohort study in patients diagnosed with dysphonia following cervical endocrine surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundAlso: voice recordings"Dynamic translaryngeal Ultrasound Motion mode ultrasound of the laryngeal region during phonation Acoustic recordings VHI questionnaires " | Other | Patients diagnosed with dysphonia following cervical endocrine surgery |
Primary outcome
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
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christophe TRESALLET, Pr, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound in people with Postoperative Dysphonia, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe TRESALLET, Pr, MD, PhD (+33 1 48 95 58 65, christophe.tresallet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.