Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT06100601

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

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Department of Rehabilitation Sciences, Ghent University (Hospital)

Ghent, East-Flanders, Belgium, 9000

Actively Recruiting

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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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