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临床试验/NCT05339906
NCT05339906Unknown不适用

Study of the Effect of the Auditory Stimulation on Stuttering Symptoms in Patients With a Deficit of Spectral Power in the EEG Beta Frequency Band

Oles Honchar Dnipro National University2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年5月25日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
25
试验地点
2
主要终点
Speech disfluencies

研究概览

简要总结

In this study, the investigators will research the efficacy of a novel auditory neuro modulating technology that leverages euphonic music tracks with broad-spectrum binaural beats to induce selective EEG spectral power changes.

详细描述

Stuttering is a speech disorder that affects more than 70 million people worldwide, limiting their ability to communicate and socialize. During recent decades, several studies have demonstrated a link between stuttering and a deficit of β EEG spectral power.

In this study, the investigators will research the efficacy of a novel auditory neuro modulating technology that leverages euphonic music tracks with broad-spectrum binaural beats to induce selective EEG spectral power changes. Participants are adults with stuttering and without speech disfluencies from the control group will expose to euphonic binaural stimuli for 5 minutes. The brain electrical activity patterns (EEG) and ECG bio-signals will record prior to, during, and after exposure.

研究设计

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

入排标准

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

入选标准

  • Adults with stuttering (stammering) symptoms;

排除标准

  • Hearing disabilities;
  • Applying other drugs or devices simultaneously;

结局指标

主要结局

Speech disfluencies

时间窗: The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation

The total number of repetitions, blocks and prolongations during the speech (assessed by speech therapist) measured before, just after and 10 minutes after auditory stimulation

次要结局

  • Heart Rate Variability Stress Index [a.u.](The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation)
  • Heart Rate Variability meanRR [ms](The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation)
  • Heart Rate Variability Total Power [ms^2](The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation)
  • Heart Rate Variability SDNN [ms](The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation)
  • Heart Rate Variability RMSSD [ms](The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation)
  • EEG spectral power in beta frequency range, [uV^2](The outcome measure will be assessed between 5-minute intervals before stimulation, just after and 10 minutes after stimulation)

研究者

发起方
Oles Honchar Dnipro National University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dmytro Chernetchenko

PhD, Associate Professor

Oles Honchar Dnipro National University

研究点 (2)

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