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Search / Trial NCT06100601

Autonomic Dysfunction in Functional Dysphonia

Launched by UNIVERSITY GHENT · Oct 20, 2023

Trial Information

Current as of August 25, 2025

Recruiting

Keywords

Autonomic Nervous System, Functional Dysphonia, Heart Rate Variability, Psychophysiology

ClinConnect Summary

This clinical trial is studying a condition called functional dysphonia, which is a voice disorder that occurs without any physical cause. The researchers want to understand how often symptoms related to autonomic dysfunction (issues with the automatic functions of the body, like heart rate and breathing) happen in people with functional dysphonia compared to healthy individuals. They are also testing a new therapy that helps regulate the autonomic nervous system, called ANS therapy, to see if it works better than standard voice therapy or a combination of both treatments.

To participate in the study, you should be between 18 and 60 years old and diagnosed with functional dysphonia by a specialist. The study will not include anyone currently receiving voice therapy, those with other voice disorders, or individuals with certain health conditions. Participants can expect to be part of a structured program where they will receive either the new therapy, standard therapy, or both, and their progress will be monitored over time. This research aims to improve treatment options for people struggling with voice disorders.

Gender

ALL

Eligibility criteria

  • Patients with functional dysphonia will be recruited from a treatment-seeking population consulting at the voice clinic of Ghent University Hospital. Inclusion criteria are all genders, all ethnicities, aged 18 - 60 years (to exclude voice-related changes due to puberty/mutation or aging/presbyphonia), diagnosed with FD by an experienced otorhinolaryngologist and SLP (defined by a voice disorder in the absence of organic or structural mucosal disease and/or neuropathology sufficient to explain the voice disturbance (Roy et al., 2003), as determined with strobovideolaryngoscopy and a multidimensional voice assessment). Exclusion criteria include: being diagnosed with an organic voice disorder, current participation in voice therapy, practice of breathing exercises including mediation and yoga, current participation in psychotherapy or physical rehabilitation, pharmacological treatment (i.e. antidepressants, antipsychotics, heart medication, antihypertensives, inhalers), previous phonosurgical interventions, lung diseases, endocrinologic diseases, metabolic diseases, cardiovascular diseases, neurologic diseases, nasal or ear diseases, pregnancy, asthma, smoking or drug consumption.
  • For the vocally healthy controls, inclusion criteria are all genders, all ethnicities, aged 18 - 60 years, and matched with the FD groups by age and gender. The same exclusion criteria as above apply, with the addition of: 'diagnosed with FD'.

About University Ghent

University Ghent is a prestigious Belgian research institution renowned for its commitment to advancing medical science and improving patient care through innovative clinical trials. With a multidisciplinary approach, the university fosters collaboration among leading experts in various fields, ensuring rigorous study design and ethical standards. University Ghent is dedicated to exploring new therapeutic modalities and enhancing healthcare outcomes, making significant contributions to both local and global health landscapes. Its state-of-the-art facilities and emphasis on research excellence position it as a pivotal sponsor in the realm of clinical research.

Locations

Ghent, East Flanders, Belgium

Patients applied

0 patients applied

Trial Officials

Kristiane Van Lierde, PhD

Principal Investigator

University Ghent

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported