Actively Recruiting
Autonomic Dysfunction in Functional Dysphonia: A Randomized Controlled Trial Comparing ANS Regulation Therapy and Conventional Voice Therapy
Led by University Ghent · Updated on 2023-10-25
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Ghent
Lead Sponsor
U
Universiteit Antwerpen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying autonomic dysfunction in patients with functional dysphonia (FD), a voice disorder without clear organic cause, to better understand its underlying psychophysiology and improve therapy options. The study includes both a case-control comparison with vocally healthy individuals matched by age and gender, and a randomized controlled trial to evaluate a novel autonomic nervous system (ANS) regulation therapy alongside conventional voice therapy (CVT). The goal is to assess the frequency of symptoms related to autonomic dysfunction and compare treatment effects on voice and autonomic function. The trial involves three treatment groups for patients with FD: ANS regulation therapy using heart rate variability biofeedback, conventional voice therapy (CVT), and a combination of both therapies. Each participant practices daily for 20 minutes over one month, including one weekly clinic session supervised by a therapist and home sessions tracked by specialized apps and heart rate monitors. The ANS therapy focuses on personalized slow-paced breathing exercises, while the CVT includes voice education, hygiene, posture, breathing, and vocal exercises. Participants will be assessed before treatment, immediately after one month of therapy, and at three months follow-up. Evaluations include physiological measures like heart rate variability, respiration rate, skin conductance, and psychological questionnaires related to stress and anxiety. Voice assessments include the Dysphonia Severity Index, acoustic voice quality, and patient-reported voice outcomes. The study aims to monitor changes in autonomic and voice function over time to inform future treatment approaches for FD.
CONDITIONS
Brief 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
- Voice disorder without organic or structural mucosal disease or neuropathology sufficient to explain the voice disturbance
- Treatment-seeking patients consulting at the voice clinic of Ghent University Hospital
You will not qualify if you...
- Diagnosed with an organic voice disorder
- Currently participating in voice therapy
- Practice of breathing exercises including meditation and yoga
- Currently in psychotherapy or physical rehabilitation
- Taking pharmacological treatments such as antidepressants, antipsychotics, heart medications, antihypertensives, or inhalers
- Previous phonosurgical interventions
- Presence of lung, endocrinologic, metabolic, cardiovascular, neurologic, nasal, or ear diseases
- Pregnancy
- Asthma
- Smoking or drug consumption
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 month
Participants receive one of three behavioral therapies for functional dysphonia: ANS regulation therapy, conventional voice therapy (CVT), or a combination of both. Each therapy involves daily 20-minute practice sessions for 1 month, including one weekly in-clinic session and other sessions practiced at home with app tracking.
Weekly in-clinic visits plus daily home practice
Duration - 3 months
Participants are assessed to evaluate changes in autonomic function and voice outcomes immediately after therapy and again at 3 months post-treatment.
2 visits (in-person) after treatment completion
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
E
Evelien D'haeseleer, PhD
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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