Actively Recruiting
Autonomic Dysfunction in Functional Dysphonia
Led by University Ghent · Updated on 2023-10-25
100
Participants Needed
1
Research Sites
164 weeks
Total Duration
On this page
Sponsors
U
University Ghent
Lead Sponsor
U
Universiteit Antwerpen
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Autonomic Dysfunction in Functional Dysphonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All genders and ethnicities aged 18 to 60 years
- Diagnosed with functional dysphonia by an experienced otorhinolaryngologist and speech-language pathologist
- Diagnosis confirmed by strobovideolaryngoscopy and multidimensional voice assessment
- For vocally healthy controls: matched by age and gender to FD patients
You will not qualify if you...
- Diagnosed with an organic voice disorder
- Currently participating in voice therapy or practicing breathing exercises including meditation and yoga
- Currently undergoing psychotherapy or physical rehabilitation
- Using pharmacological treatments such as antidepressants, antipsychotics, heart medication, antihypertensives, or inhalers
- Previous phonosurgical interventions
- Having lung, endocrinologic, metabolic, cardiovascular, neurologic, nasal, or ear diseases
- Pregnant
- Asthma
- Smoking or drug consumption
- For healthy controls: diagnosed with functional dysphonia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Rehabilitation Sciences, Ghent University (Hospital)
Ghent, East-Flanders, Belgium, 9000
Actively Recruiting
Research Team
I
Iris Meerschman, PhD
CONTACT
E
Evelien D'haeseleer, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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