Functional Voice DisorderNCT06100601
Autonomic Dysfunction in Functional Dysphonia
A study testing ANS regulation therapy, conventional voice therapy (CVT) and ANS regulation therapy + CVT in people with Functional Voice Disorder and Psychogenic Voice Disorder, run by University Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Voice Disorder, Psychogenic Voice Disorder, Muscle Tension Dysphonia
- What is being tested?
- ANS regulation therapy, conventional voice therapy (CVT) and ANS regulation therapy + CVT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Oct 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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'.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Evelien D'haeseleer, PhD contact
Belgium1 site, 1 recruiting
- Recruiting
Department of Rehabilitation Sciences, Ghent University (Hospital)
Ghent, East-Flanders, 9000
Iris Meerschman, PhD, +32499294636, iris.meerschman@ugent.be
Kristiane Van Lierde, PhD, kristiane.vanlierde@ugent.be
About this study
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).
Read the 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.
- Being tested
- ANS regulation therapy, conventional voice therapy (CVT), ANS regulation therapy + CVT
- Keywords
- Autonomic nervous system, functional dysphonia, heart rate variability, psychophysiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANS regulation therapyBehavioural
Also called HRV biofeedback
innovative intervention for functional dysphonia
conventional voice therapy (CVT)Behavioural
conventional voice therapy traditionally provided for functional dysphonia
ANS regulation therapy + CVTBehavioural
combination of ANS regulation therapy and CVT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: ANS regulation therapy + CVT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
Secondary outcomes (12)
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)
Measured: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
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
Measured: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
Skin conductance level
Skin conductance level (in µS) will measure the tonic electrodermal activity and reflects increased SA (Dawson et al., 2017).
Measured: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
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).
Measured: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
The Depression Anxiety and Stress Scale 21
The Depression Anxiety and Stress Scale 21 (DASS-21; Lovibond PF \& Lovibond SH, 1995; Dutch Version: De Beurs et al., 2001) is a validated 21-item checklist covering 3 subscales measuring the emotional states of depression (e.g. I felt that I had nothing to look forward to), anxiety (e.g. I felt scared with any good reason) and stress (e.g. I found myself getting agitated).
Measured: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
The Posttraumatic Stress Disorder Checklist for DSM-5
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5; Weathers et al., 2013; Dutch version: Boeschoten et al., 2014; De Beurs et al., 2020) is a validated 20-item checklist that assesses the DSM-5 symptoms of PTSD. It exists of 4 clusters: re-experiencing (e.g. Repeated, disturbing dreams of the stressful experience), avoidance (e.g. Avoiding memories, thoughts, or feelings related to the stressful experience), numbing (e.g. Loss of interest in activities that you used to enjoy), and arousal factors (e.g. Irritable behavior, angry outbursts, or acting aggressively).
Measured: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
The short version of the Self Regulation Questionnaire
The short version of the Self Regulation Questionnaire (Brown \& Miller, 1999; Carey et al., 2004; Neal \& Carey, 2005) is a 31-item self-report measure of the ability to self-regulate one's behavior (e.g. Once I have a goal, I can usually plan how to reach it, I have a lot of willpower).
Measured: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (Dutch Version: Buysse et al., 1989) is a validated 19-item index assessing overall sleep quality. It consists of 7 subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction.
Measured: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
Laryngeal function
A flexible strobovideolaryngoscopy will be performed by an experienced otorhinolaryngologist to visualize the laryngeal function and (supra)glottic activity. The video samples will be evaluated randomly and blindly by a specialized otorhinolaryngologists and SLP to assure interrater reliability; 15% of the samples will be randomly repeated to assess intrarater reliability. The Voice-Vibratory Assessment with Laryngeal Imaging (VALI) rating form (Poburka et al., 2017) will be used for these evaluations.
Measured: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
Acoustic Voice Quality Index (AVQI)
An instrumental voice assessment will be performed by an experienced SLP, different from the therapist. Acoustic measures will be obtained by the Computerized Speech Lab (KayPENTAX, Montvale, NY) and the software program Praat (Boersma \& Weenink, 2013). A Shure SM-48 and an AKG Lyra microphone will be used. Two objective multiparametric indices will quantify voice quality: the DSI (Wuyts et al., 2000) and the AVQI (Maryn et al., 2010).
Measured: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
Consensus Auditory Perceptual Evaluation of Voice
An auditory-perceptual (subjective) voice evaluation will be performed using the Consensus Auditory Perceptual Evaluation of Voice (Kempster et al., 2009). Speech samples (sustained vowel and continuous speech) will be evaluated randomly and blindly by 2 experienced SLPs to assure interrater reliability; 15% of the samples will be randomly repeated to assess intrarater reliability.
Measured: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
voice-related patient-reported outcome measures
The Voice Handicap Index (Jacobson et al., 1997; Dutch version: De Bodt et al., 2000), the Vocal Tract Discomfort Scale (Mathieson et al., 2009; Dutch version: Luyten et al., 2016) and the Vocal Fatigue Index (Nanjundeswaran et al., 2015) will be administered to evaluate the psychosocial impact, vocal tract discomfort and vocal fatigue associated with dysphonia.
Measured: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start10 Oct 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional Voice DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1) Case-control study Part 2) Randomized-controlled trial (3 arms)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen, University of Utah
- Responsible party
- Sponsor
- Investigators
- Kristiane Van Lierde, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100601
- Sponsor's protocol ID
- BOF23/PDO/059
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meerschman I, D'haeseleer E, Vanderhasselt MA, Claeys S, Vonck K, Vergauwe R, Van Nuffelen G, Desuter G, Roy N, Van Lierde K. Exploring autonomic dysfunction in functional dysphonia: A protocol for a case-control study and a randomized controlled trial. Int J Lang Commun Disord. 2024 Nov-Dec;59(6):2723-2736. doi: 10.1111/1460-6984.13111. Epub 2024 Sep 10.
PubMed 39254146
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Dysfunction in Functional Dysphonia
- ClinicalTrials.gov ID
- NCT06100601
- Acronym / sponsor ID
- BOF23/PDO/059
- Keywords
- Autonomic nervous system, functional dysphonia, heart rate variability, psychophysiology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen, University of Utah
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Part 1) Case-control study Part 2) Randomized-controlled trial (3 arms)
| Arm | Type | Receives |
|---|---|---|
| Autonomic nervous system (ANS) regulation therapy | Experimental | Behavioral: ANS regulation therapyHRV 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. |
| conventional voice therapy (CVT) | Active comparator | Behavioral: 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. |
| ANS regulation therapy + CVT | Active comparator | Behavioral: ANS regulation therapy + CVTThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANS regulation therapyAlso: HRV biofeedbackinnovative intervention for functional dysphonia | Behavioural | Autonomic nervous system (ANS) regulation therapy |
| conventional voice therapy (CVT)conventional voice therapy traditionally provided for functional dysphonia | Behavioural | conventional voice therapy (CVT) |
| ANS regulation therapy + CVTcombination of ANS regulation therapy and CVT | Behavioural | ANS regulation therapy + CVT |
Primary outcome
heart rate variability (HRV)
Time frame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
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.
Dysphonia Severity Index (DSI)
Time frame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
The DSI is an objective multiparametric indices that quantifies voice quality (Wuyts et al., 2000)
12 secondary outcomes
Pre-ejection period
Time frame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
Respiration rate
Time frame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
Skin conductance level
Time frame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
The Neuroception of Psychological Safety Scale
Time frame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
The Depression Anxiety and Stress Scale 21
Time frame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
The Posttraumatic Stress Disorder Checklist for DSM-5
Time frame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
The short version of the Self Regulation Questionnaire
Time frame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
The Pittsburgh Sleep Quality Index
Time frame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
Laryngeal function
Time frame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
Acoustic Voice Quality Index (AVQI)
Time frame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
Consensus Auditory Perceptual Evaluation of Voice
Time frame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
voice-related patient-reported outcome measures
Time frame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Derived from this study: PubMed 39254146Meerschman I, D'haeseleer E, Vanderhasselt MA, Claeys S, Vonck K, Vergauwe R, Van Nuffelen G, Desuter G, Roy N, Van Lierde K. Exploring autonomic dysfunction in functional dysphonia: A protocol for a case-control study and a randomized controlled trial. Int J Lang Commun Disord. 2024 Nov-Dec;59(6):2723-2736. doi: 10.1111/1460-6984.13111. Epub 2024 Sep 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Evelien D'haeseleer, PhD contact
Kristiane Van Lierde, PhD principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANS regulation therapy, conventional voice therapy (CVT) and ANS regulation therapy + CVT in people with Functional Voice Disorder and Psychogenic Voice Disorder, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iris Meerschman, PhD (+32499294636, iris.meerschman@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate variability (HRV) (time frame: baseline (before the intervention), 1 months (after the intervention), 3 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06100601, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.