Investigating Autonomic Dysfunction in Voice Disorders
Official title: Autonomic Dysfunction in Functional Dysphonia
Run by University Ghent · NCT06100601 · Data updated 2026-11-12
This study is testing a new therapy that focuses on the nervous system to see if it helps people with voice disorders feel better compared to those without the disorder.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University Ghent Academic / other |
| Locations | 1 site (Ghent, East-Flanders) |
| Status | Recruiting |
| Started | October 10, 2023 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | October 25, 2023 |
| Trial ID | NCT06100601 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals aged 18 to 60 diagnosed with functional dysphonia, without any organic voice disorders.
✕Probably not a fit
Patients with organic voice disorders or those currently undergoing other forms of therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This research project aims to explore the relationship between autonomic dysfunction and functional dysphonia by comparing patients with this voice disorder to healthy controls. It will assess the frequency of autonomic symptoms in both groups and evaluate the effectiveness of a novel therapy focused on autonomic nervous system regulation, alongside conventional voice therapy. The study will utilize a case-control design and a randomized controlled trial to gather comprehensive data on treatment outcomes. By understanding the psychophysiological mechanisms involved, the research seeks to improve therapeutic approaches for functional dysphonia.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients suffering from functional dysphonia, potentially improving their quality of life.
How similar studies have gone: While the exploration of autonomic dysfunction in voice disorders is relatively novel, similar approaches in other psychological and psychiatric fields have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion 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'.
Where it's running
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Department of Rehabilitation Sciences, Ghent University (Hospital)
Ghent, East-Flanders, Belgium Recruiting
Study contacts
- Principal investigator: Kristiane Van Lierde, PhD — University Ghent
- Study coordinator: Iris Meerschman, PhD
- Email: iris.meerschman@ugent.be
- Phone: +32499294636
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Neck vibration plus voice therapy for muscle tension dysphonia
This trial will test whether adding gentle translaryngeal (neck) vibration to standard voice therapy helps adults with muscle tension dysphonia improve their voice.
-
Voice therapy guided by the RTSS-Voice standardized coding system
This project will test whether using a standardized coding system (RTSS-Voice) to document voice therapy sessions helps people with muscle tension dysphonia improve their voice.
-
Biofeedback and voice therapy for vocal hyperfunction
This study is testing if adding biofeedback to regular voice therapy can help people with vocal hyperfunction improve their voice use in everyday life.
-
Exploring genetic and brain imaging factors in laryngeal dystonia
This study is trying to see how genetics and brain changes are linked in people with laryngeal dystonia to help understand the condition better and find early signs in those at risk.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.