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Autonomic Dysfunction in Functional Dysphonia

NCT06100601 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-10-25

No results posted yet for this study

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).

Conditions

  • Functional Voice Disorder
  • Psychogenic Voice Disorder
  • Muscle Tension Dysphonia

Interventions

BEHAVIORAL

ANS regulation therapy

innovative intervention for functional dysphonia

BEHAVIORAL

conventional voice therapy (CVT)

conventional voice therapy traditionally provided for functional dysphonia

BEHAVIORAL

ANS regulation therapy + CVT

combination of ANS regulation therapy and CVT

Sponsors & Collaborators

  • Universiteit Antwerpen

    collaborator OTHER

  • University of Utah

    collaborator OTHER

  • University Ghent

    lead OTHER

Principal Investigators

  • Kristiane Van Lierde, PhD · University Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-10
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Belgium

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06100601 on ClinicalTrials.gov