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临床试验/NCT07474740
NCT07474740进行中(未招募)不适用

Characterization and Treatment of Essential Vocal Tremor

University of Texas at Austin1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月4日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Patient-reported outcome measures

研究概览

简要总结

The goal of this study is to evaluate the efficacy of voice therapy for neurogenic voice disorders. The main questions are:

Does voice therapy improve patient-reported quality of life in speakers with neurogenic voice disorders? Does voice therapy improve listener perception of voice in speakers with neurogenic voice disorders? Does voice therapy improve acoustical analyses of voice in speakers with neurogenic voice disorders? Does voice therapy improve physiologic function in speakers with neurogenic voice disorders?

详细描述

Neurogenic voice disorders negatively impact communication-related quality of life for millions of patients. Yet current options for medical treatment including pharmacological and surgical interventions do not consistently improve voice and can have adverse effects. Although some patients with neurogenic voice disorders receive behavioral treatment like voice therapy, systematic treatment research evaluating the efficacy of behavioral treatment is limited. For example, in speakers with voice disorders related to essential tremor, the most common movement disorder in the world, only five studies have evaluated the effects of behavioral interventions. Of these studies, two were case studies (N=1, N=2), two were single-case experiments (N=1, N=3), and one was a prospective group study comparing control and experimental conditions (N=10). These studies evaluated a variety of treatment ingredients using various functional, perceptual, and acoustical treatment outcomes. However, some treatment ingredients and outcome measures were not specific to the underlying voice impairments in essential tremor. In neurogenic voice disorders with other etiologies like dystonia, more studies with larger sample sizes have been conducted. However, only eight studies have been published: two were case studies (N=1, N=1), one was a single-case experiment (N=1), one was a prospective group study comparing pre- and post-treatment phases (N=36), one was a retrospective group study comparing control and experimental conditions (N=37), one was a randomized cross-over study (N=9), one was a non-randomized controlled trial (N=17), and one was a randomized controlled trial (N=31). These studies also evaluated various treatment ingredients using functional, perceptual, and acoustical outcomes, as well as aerodynamic and acoustic outcomes. But again, some treatment ingredients and outcome measures were not specific to the underlying voice impairments related to dystonia. Finally, although a considerably higher number of treatment studies with greater sample sizes have been conducted with speakers who have voice disorders related to Parkinson's disease, the most widely studied treatment ingredients have limitations. For example, Lee Silverman Voice Therapy requires high-intensity, high-frequency treatment provided by speech-language pathologists with specialized training, and expiratory muscle strength training is also high-frequency, high-intensity treatment that requires specific equipment and physiologic capabilities. Thus, there is an important need for systematic treatment research in speakers with neurogenic voice disorders using treatment ingredients and outcome measures that are specific to patients' neurophysiologic impairments and functional limitations.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of essential tremor by a physician
  • Self-reported, physician-identified, or speech-language pathologist-identified vocal tremor
  • Ability to speak and read English
  • Ability to follow instructions and pay attention to tasks

排除标准

  • History of surgery on the oral cavity, larynx, pharynx, or respiratory system that currently affects speech or voice
  • Current respiratory disorder unrelated to essential tremor that affects speech or voice
  • Score 20 points or below on the Mini-Mental Status Examination

研究组 & 干预措施

Breathy voice as a compensatory strategy for vocal tremor

Experimental

干预措施: Breathy voice (Behavioral)

结局指标

主要结局

Patient-reported outcome measures

时间窗: Participants will complete ratings during the treatment phase at the beginning of the first treatment session and at the end of the last treatment session.

Participants will be asked to rate their perception of the voice strategy on a 6-point Likert scale (0 = not at all, 5 = very much): 1) My voice was shaky when I used the strategy, 2) It was effortful to speak when I used the strategy, 3) It was difficult to use the strategy, 4), I liked the sound of my voice when I used the strategy.

Auditory-perceptual ratings

时间窗: Listeners will rate samples from all study phases within two years after all data have been collected from all study participants.

Listeners will be asked to complete perceptual ratings for the participants' voices by marking the severity of the 'shakiness' on a visual-analog scale (0 = not shaky, 100 = very shaky).

Acoustical analyses - extent of modulation

时间窗: Audio recordings from all study phases will be analyzed within 2 years after completing data collection.

The extent of fundamental frequency and intensity modulation in percent will be measured in participants' sustained vowels as an estimate of tremor magnitude.

Acoustical analyses - modulation rate

时间窗: Audio recordings from all study phases will be analyzed within 2 years after completing data collection.

The rate of fundamental frequency and intensity modulation in Hertz will be measured in participants' sustained vowels as an estimate of tremor speed.

Acoustical analyses - cepstral peak prominence

时间窗: Audio recordings from all study phases will be analyzed within 2 years after completing data collection.

The cepstral peak prominence will be measured in participants' sustained vowels and connected speech as an estimate of 'breathiness.'

次要结局

  • Acoustical analyses - voice breaks(Audio recordings from all study phases will be analyzed within 2 years after completing data collection.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rosemary Lester-Smith

Associate Professor of Speech, Language, and Hearing Sciences

University of Texas at Austin

研究点 (1)

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