NCT06100601 Autonomic Dysfunction in Functional Dysphonia
| NCT ID | NCT06100601 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Ghent |
| Condition | Functional Voice Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-10-10 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-10-10 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The first objective of this research project is to compare the occurrence and frequency of symptoms and/or disorders related to autonomic dysfunction in patients with functional dysphonia with gender- and age-matched vocally healthy controls, using a case-control study. The second objective is to compare the effects of a novel therapy based on autonomic nervous system regulation (i.e., ANS therapy: heart rate variability biofeedback), for functional dysphonia versus coventional voice therapy (CVT) alone or in combination with ANS regulation therapy (i.e., ANS therapy + CVT), using a longitudinal randomized controlled trial (RCT).
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'.
Contact & Investigator
Kristiane Van Lierde, PhD
PRINCIPAL INVESTIGATOR
University Ghent
Frequently Asked Questions
Who can join the NCT06100601 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Functional Voice Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06100601 currently recruiting?
Yes, NCT06100601 is actively recruiting participants. Contact the research team at iris.meerschman@ugent.be for enrollment information.
Where is the NCT06100601 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT06100601 clinical trial?
NCT06100601 is sponsored by University Ghent. The principal investigator is Kristiane Van Lierde, PhD at University Ghent. The trial plans to enroll 100 participants.