Status:

RECRUITING

Autonomic Dysfunction in Functional Dysphonia

Lead Sponsor:

University Ghent

Collaborating Sponsors:

Universiteit Antwerpen

University of Utah

Conditions:

Functional Voice Disorder

Psychogenic Voice Disorder

Eligibility:

All Genders

18-60 years

Phase:

NA

Brief 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-...

Detailed Description

Background. Although psychological factors have been implicated in patients with functional dysphonia (FD), conventional treatment typically targets the aberrant voice symptoms exclusively. Yet, sympt...

Eligibility Criteria

Patients with functional dysphonia will be recruited from a treatment-seeking population consulting at the voice clinic of Ghent University Hospital. Inclusion criteria are all genders, all ethnicities, aged 18 - 60 years (to exclude voice-related changes due to puberty/mutation or aging/presbyphonia), diagnosed with FD by an experienced otorhinolaryngologist and SLP (defined by a voice disorder in the absence of organic or structural mucosal disease and/or neuropathology sufficient to explain the voice disturbance (Roy et al., 2003), as determined with strobovideolaryngoscopy and a multidimensional voice assessment). Exclusion criteria include: being diagnosed with an organic voice disorder, current participation in voice therapy, practice of breathing exercises including mediation and yoga, current participation in psychotherapy or physical rehabilitation, pharmacological treatment (i.e. antidepressants, antipsychotics, heart medication, antihypertensives, inhalers), previous phonosurgical interventions, lung diseases, endocrinologic diseases, metabolic diseases, cardiovascular diseases, neurologic diseases, nasal or ear diseases, pregnancy, asthma, smoking or drug consumption.

For the vocally healthy controls, inclusion criteria are all genders, all ethnicities, aged 18 - 60 years, and matched with the FD groups by age and gender. The same exclusion criteria as above apply, with the addition of: 'diagnosed with FD'.

Key Trial Info

Start Date :

October 10 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06100601

Start Date

October 10 2023

End Date

December 1 2026

Last Update

October 25 2023

Active Locations (1)

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1

Department of Rehabilitation Sciences, Ghent University (Hospital)

Ghent, East-Flanders, Belgium, 9000

Autonomic Dysfunction in Functional Dysphonia | DecenTrialz