Autonomic Dysfunction in Functional Dysphonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-10

Study Completion Date

2026-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Functional Voice Disorder Psychogenic Voice Disorder Muscle Tension Dysphonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Part 1) Case-control study Part 2) Randomized-controlled trial (3 arms)

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Autonomic nervous system (ANS) regulation therapy

HRV biofeedback is a non-invasive intervention that focuses on increasing heart rate oscillations through real-time feedback and slow-paced breathing training (Lehrer et al., 2020; Laborde et al., 2022; Pizzoli et al., 2021). Participants will practice 20 min a day (2 sessions of 10 min) for 1 month. One weekly session will be organized in the clinic under the guidance of the therapist (individual sessions), the other sessions will be organized at home, and tracked by a chest strap heart rate monitor (Polar H10) and the Elite HRV app (elitehrv.com). First, the resonance frequency (RF) (i.e. respiration rate with the highest HRV) will be personalized for each participant. Biofeedback slow-paced breathing exercises in the app will then be customized based on this RF (40% inhale, 60% exhale: e.g. 6 bpm: 4s inhale, 6s exhale). Participants will be asked to breathe in through the nose and breathe out through pursed lips, following the breath pacer with visual feedback.

Group Type EXPERIMENTAL

ANS regulation therapy

Intervention Type BEHAVIORAL

innovative intervention for functional dysphonia

conventional voice therapy (CVT)

The CVT will be based on Meerschman et al. (2019). This therapeutic program has been proven effective in voice therapy and is the standard clinical care for FD patients. The program is a combination of education, vocal hygiene, posture, local relaxation, costo-abdominal breathing, resonant voice, voice placing, forward focus, voice onset, semi-occluded vocal tract exercises and laryngeal manipulation. Identical to the ANS regulation therapy, participants will practice 20 min a day for 1 month. One weekly session will be organized in the clinic under the guidance of the therapist (individual sessions), the other sessions will be organized at home and tracked by the RedCap app.

Group Type ACTIVE_COMPARATOR

conventional voice therapy (CVT)

Intervention Type BEHAVIORAL

conventional voice therapy traditionally provided for functional dysphonia

ANS regulation therapy + CVT

The third group will receive a combination of both therapies. The same frequency and duration of practice (20 min a day for 1 month) will apply. They will also receive one weekly session in the clinic under the guidance of the therapist (individual sessions) and the other sessions will be completed at home, tracked by the Elite HRV app and the RedCap app.

Group Type ACTIVE_COMPARATOR

ANS regulation therapy + CVT

Intervention Type BEHAVIORAL

combination of ANS regulation therapy and CVT

Interventions

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ANS regulation therapy

innovative intervention for functional dysphonia

Intervention Type BEHAVIORAL

conventional voice therapy (CVT)

conventional voice therapy traditionally provided for functional dysphonia

Intervention Type BEHAVIORAL

ANS regulation therapy + CVT

combination of ANS regulation therapy and CVT

Intervention Type BEHAVIORAL

Other Intervention Names

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HRV biofeedback

Eligibility Criteria

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Inclusion 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'.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes