Autonomic Dysfunction in Functional Dysphonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity Ghent
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
ANS regulation therapy
Behavioralinnovative intervention for functional dysphonia
conventional voice therapy (CVT)
Behavioralconventional voice therapy traditionally provided for functional dysphonia
ANS regulation therapy + CVT
Behavioralcombination of ANS regulation therapy and CVT
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Autonomic nervous system (ANS) regulation therapyExperimental treatment 1 intervention
Group B: conventional voice therapy (CVT)Active comparator 1 intervention
Group C: ANS regulation therapy + CVTActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
baseline (before the intervention), 1 months (after the intervention), 3 months follow-up2
Dysphonia Severity Index (DSI)
The DSI is an objective multiparametric indices that quantifies voice quality (Wuyts et al., 2000)
Time frame
baseline (before the intervention), 1 months (after the intervention), 3 months follow-upSecondary outcomes
1
Pre-ejection period
The pre-ejection period is the time between the onset of depolarization of the left ventricle and the opening of the aortic valves and will be calculated as a cardiovascular index of SA (Lozano et al., 2007)
Time frame
baseline (before the intervention), 1 months (after the intervention), 3 months follow-up2
Respiration rate
Respiration rate (in bpm) will be determined via thoracic impedance (De Geus et al., 1995). For each respiratory cycle, the total cycle time between the start of inspiration and the end of expiration will be extrapolated to a per-minute respiration rate
Time frame
baseline (before the intervention), 1 months (after the intervention), 3 months follow-up3
Skin conductance level
Skin conductance level (in µS) will measure the tonic electrodermal activity and reflects increased SA (Dawson et al., 2017).
Time frame
baseline (before the intervention), 1 months (after the intervention), 3 months follow-up4
The Neuroception of Psychological Safety Scale
The Neuroception of Psychological Safety Scale (NPSS; Morton et al., 2022) is a psychometrically valid measure determining psychological, relational and physiological safety. It consists of 29 items subdivided into 3 subscales: compassion (e.g. I felt caring), social engagement (e.g. I felt accepted by others) and body sensations (e.g. My body felt relaxed).
Time frame
baseline (before the intervention), 1 months (after the intervention), 3 months follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov