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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03906877
Other study ID # 2018/03OCT/365
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2019
Est. completion date September 30, 2023

Study information

Verified date November 2023
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to understand how early intervention could impact reinnervation of the recurrent laryngeal nerve (which innervates the vocal cord), recovery of mobility of the paralyzed vocal cord and / or vocal recovery in the case of unilateral vocal fold paralysis. To achieve this goal we must therefore carry out a complete outcomes assessment of different intervention methods (voice therapy and injection laryngoplasty), which are offered to UVFP (unilateral vocal fold paralysis) patients in the early stage (< 3 months). Their respective impacts on the central and peripheral nervous system and on the voice quality will be assessed, taking into account factors related to the severity of the paralysis.


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Study Design


Intervention

Procedure:
Acid hyaluronic injection laryngoplasty
Hyaluronic acid is injected into the paralyzed vocal fold
Behavioral:
Voice therapy
15 sessions of thirty minutes of voice therapy, twice a week, and home practice. This voice management will be specific to unilateral vocal fold paralysis and will focus on three objectives: reinforcement of the vocal muscle, glottal closure and glottal opening. These three objectives will be worked through different vocal exercises (on voiced phonemes) and breathing exercises
Other:
Sham of injection
Injection of physiological saline under the skin of the neck (sham of injection).
Sham of voice therapy
15 sessions of thirty minutes of voice therapy, twice a week, and home practice. This voice management will not be specific to UVFP but may allow patients to improve their vocal gesture.

Locations

Country Name City State
Belgium Cliniques Universitaires St Luc Brussels

Sponsors (1)

Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Laryngeal recurrent nerve reinnervation Defined through qualitative laryngeal electromyography 9 to 12 months after paralysis
Primary Recovery of the vocal fold mobility Videostroboscopy examination to analyse vocal folds movements in three dimensions 9 to 12 months after paralysis
Primary Voice recovery Multidimensional voice assessment (based on anamnestic interview, Maximum Phonation Time in sec, Mean Air Flow in ml/sec, Mean subglottic pressure in cmH2O, Jitter in %, Shimmer in %, Noise-to-harmonic ratio, phonetogram, smoothed cepstral peak prominence in %, Voice Handicap Index - VHI-30 (*total* : 0-120, higher value = worse outcome), Medical Outcomes Study 36-item Short Form Healthy Survey (*8 subscales* : 0-100, higher value = better outcome, Eating Assessment Tool-10 (*total*: 0-40, higher value = worse outcome), GRBAS-I (*6 subscales* : 0-3, higher value = worse outcome), Acoustic Voice Quality Index, Dysphonia Severity Index (DSI = 0.13 x MPT + 0.0053 x F(0)-High - 0.26 x I-Low - 1.18 x Jitter (%) + 12.4),Tonal and vocal audiometries in dB) 9 to 12 months after paralysis
Primary Changes in the neuronal pathways involved in the processing of the proprioceptive and auditory inputs Functional magnetic resonance imaging examination (tomodensitometry and connectivity) 9 to 12 months after paralysis
Primary Central auditory processes Auditory perception tasks performed using an audio headset Within 3 months after paralysis
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