Clinical trial NCT06100601: Autonomic Dysfunction in Functional Dysphonia
Official title: Autonomic Dysfunction in Functional Dysphonia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Voice Disorder
Psychogenic Voice Disorder
Muscle Tension Dysphonia
Keywords: Autonomic nervous system, functional dysphonia, heart rate variability, psychophysiology
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
name: University of Utah
First posted: 2023-10-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part 1) Case-control study Part 2) Randomized-controlled trial (3 arms)
Primary purpose: TREATMENT

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- 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).

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, symptomatic/conventional voice therapy (CVT) is not always successful, and in view of the significant adverse quality of life (QoL) impact combined with the substantial financial burden on the healthcare system and society, research is needed to elucidate the underlying pathogenesis and psychophysiology of FD and improve treatment outcomes. Given that (1) the Vagus nerve not only innervates the larynx, but helps to regulate the autonomic nervous system (ANS), (2) autonomic dysfunction is well recognized in the fields of psychology and psychiatry, but remains relatively understudied in the area of voice disorders, and, (3) many of the psychological symptoms/features commonly observed in patients with FD may reflect ANS dysregulation, we intend to investigate ANS dysfunction as a potential psychophysiological mechanism underlying FD; and, to evaluate the comparative effectiveness of a novel therapy that aims to improve ANS regulation in patients with FD.

Objectives. 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 FD 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 ANS regulation (i.e., ANS therapy: heart rate variability biofeedback), for FD versus CVT alone or in combination with ANS regulation therapy (i.e., ANS therapy + CVT), using a longitudinal randomized controlled trial (RCT).

Methods. Case-control study: Autonomic (dys)function of patients with FD will be compared with gender- and age-matched vocally healthy controls, using both physiological measures (e.g. heart rate variability, skin conductance level) and psychological patient-reported outcome measures (PROMs, e.g. Neuroception of Psychological Safety Scale, Depression Anxiety and Stress Scale). RCT: The FD group will be randomly assigned to the innovative ANS therapy group, the CVT group or the ANS therapy + CVT group. All patients will receive 1 month of treatment with 20min of daily practice. Both the autonomic assessment and the voice assessment will be performed pretherapy, immediately after therapy and at 3 months follow-up by assessors blinded to group allocation and study phase.

Expected results. Higher occurrence of symptoms and/or disorders related to autonomic dysfunction are expected in patients with FD compared with vocally healthy controls. Physiological outcomes: Lower heart rate variability, lower cardiac pre-ejection period, higher respiration rate and higher skin conductance level are hypothesized in patients with FD compared with vocally healthy controls. Psychological PROMs: Higher self-report of feelings/symptoms related to autonomic dysfunction (e.g. perceived stress, anxiety) is expected in patients with FD compared with vocally healthy controls. Autonomic function is hypothesized to improve more after the ANS therapy and the ANS therapy + CVT compared with the CVT only. Voice function is expected to improve more after the ANS therapy + CVT compared with the ANS therapy and the CVT alone.

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'.

Primary outcomes:
measure: heart rate variability (HRV)
timeFrame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
measure: Dysphonia Severity Index (DSI)
timeFrame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
Secondary outcomes:
measure: Pre-ejection period
timeFrame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
measure: Respiration rate
timeFrame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
measure: Skin conductance level
timeFrame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
measure: The Neuroception of Psychological Safety Scale
timeFrame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
measure: The Depression Anxiety and Stress Scale 21
timeFrame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
measure: The Posttraumatic Stress Disorder Checklist for DSM-5
timeFrame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
measure: The short version of the Self Regulation Questionnaire
timeFrame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
measure: The Pittsburgh Sleep Quality Index
timeFrame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
measure: Laryngeal function
timeFrame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
measure: Acoustic Voice Quality Index (AVQI)
timeFrame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
measure: Consensus Auditory Perceptual Evaluation of Voice
timeFrame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
measure: voice-related patient-reported outcome measures
timeFrame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Department of Rehabilitation Sciences, Ghent University (Hospital)
state: East-Flanders
Study officials:
affiliation: University Ghent
name: Kristiane Van Lierde, PhD
role: PRINCIPAL_INVESTIGATOR
References: