NCT03906877

Early UVFP Management Based on Neurological Evidences (UVFP = Unilateral Vocal Fold Paralysis)

Early UVFP Management Based on Neurological Evidences UVFP = Unilateral Vocal Fold Paralysis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Unilateral Vocal Cord Paralysis

Interventions

Type	Name	Description
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).
OTHER	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.

Timeline

• Start date: 2019-11-15
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2019-04-08
• Last updated: 2023-11-24

Locations

1 site across 1 country: Belgium