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临床试验/NCT06100601
NCT06100601招募中不适用

Autonomic Dysfunction in Functional Dysphonia

University Ghent2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
heart rate variability (HRV)

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

heart rate variability (HRV)

时间窗: 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)

时间窗: 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)

次要结局

  • 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 Pittsburgh Sleep Quality Index(baseline (before the intervention), 1 months (after the intervention), 3 months follow-up)
  • Consensus Auditory Perceptual Evaluation of Voice(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)
  • Acoustic Voice Quality Index (AVQI)(baseline (before the intervention), 1 months (after the intervention), 3 months follow-up)
  • The Posttraumatic Stress Disorder Checklist for DSM-5(baseline (before the intervention), 1 months (after the intervention), 3 months follow-up)
  • The short version of the Self Regulation Questionnaire(baseline (before the intervention), 1 months (after the intervention), 3 months follow-up)
  • Laryngeal function(baseline (before the intervention), 1 months (after the intervention), 3 months follow-up)
  • voice-related patient-reported outcome measures(baseline (before the intervention), 1 months (after the intervention), 3 months follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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