Autonomic Dysfunction in Functional Dysphonia

NCT06100601 | Recruiting

• 1 other identifier: BOF23/PDO/059
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Functional Voice Disorder; Psychogenic Voice Disorder; Muscle Tension Dysphonia

Keywords

Autonomic nervous system, functional dysphonia, heart rate variability, psychophysiology

Outcome Measures

Primary Outcomes (2)

• heart rate variability (HRV)

  Heart rate variability (HRV, in ms) is an autonomic index measuring the variation of the interval between consecutive heartbeats and is vagally regulated (PSA) (Thayer et al., 2009; Pizzoli et al., 2021; Singh Solorzano et al., 2022). It measures direct Vagus nerve activation potential on a cardiac level (Thayer \& Lane, 2000; Sars, 2022). High HRV is associated with high vagal tone, whereas low HRV indicates ANS dysregulation with low vagal tone and SA prominence (Idrobo-Ávila et al., 2022). HRV will be determined at rest with electrocardiography using Kubios HRV analysis software (Tarvainen et al., 2002; 2014; Niskanen et al., 2004). Ag/AgCl surface electrodes will be positioned on the participant's chest in a modified lead II configuration.

  baseline (before the intervention), 1 months (after the intervention), 3 months follow-up

• Dysphonia Severity Index (DSI)

  The DSI is an objective multiparametric indices that quantifies voice quality (Wuyts et al., 2000)

  baseline (before the intervention), 1 months (after the intervention), 3 months follow-up

Secondary Outcomes (12)

• Pre-ejection period

  baseline (before the intervention), 1 months (after the intervention), 3 months follow-up

• Respiration rate

  baseline (before the intervention), 1 months (after the intervention), 3 months follow-up

• Skin conductance level

  baseline (before the intervention), 1 months (after the intervention), 3 months follow-up

• The Neuroception of Psychological Safety Scale

  baseline (before the intervention), 1 months (after the intervention), 3 months follow-up

• The Depression Anxiety and Stress Scale 21

  baseline (before the intervention), 1 months (after the intervention), 3 months follow-up

Study Arms (3)

Autonomic nervous system (ANS) regulation therapy

EXPERIMENTAL

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.

Behavioral: ANS regulation therapy

conventional voice therapy (CVT)

ACTIVE COMPARATOR

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.

Behavioral: conventional voice therapy (CVT)

ANS regulation therapy + CVT

ACTIVE COMPARATOR

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.

Behavioral: ANS regulation therapy + CVT

Interventions

ANS regulation therapy BEHAVIORAL

innovative intervention for functional dysphonia

Also known as: HRV biofeedback

Autonomic nervous system (ANS) regulation therapy

conventional voice therapy (CVT) BEHAVIORAL

conventional voice therapy traditionally provided for functional dysphonia

conventional voice therapy (CVT)

ANS regulation therapy + CVT BEHAVIORAL

combination of ANS regulation therapy and CVT

ANS regulation therapy + CVT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• University Ghent: lead
• Universiteit Antwerpen: collaborator
• University of Utah: collaborator

Study Sites (1)

Department of Rehabilitation Sciences, Ghent University (Hospital)

Ghent, East-Flanders, 9000, Belgium

RECRUITING

Study Officials

• Kristiane Van Lierde, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris Meerschman, PhD

CONTACT

+32499294636; iris.meerschman@ugent.be

Evelien D'haeseleer, PhD

CONTACT

evelien.dhaeseleer@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 25, 2023
• Study Start: October 10, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 25, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)