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โ† Trials
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Autonomic Dysfunction in Functional Dysphonia

RecruitingNAAges 18 Years - 60 YearsAllUniversity Ghent
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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'.
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What it tests

  • ANS regulation therapy
  • conventional voice therapy (CVT)
  • ANS regulation therapy + CVT
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Where

1 site
Department of Rehabilitation Sciences, Ghent University (Hospital)
Ghent, Belgium
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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