Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID06100601

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

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
  • 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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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