跳至主要内容
临床试验/NCT04818021
NCT04818021终止不适用

Contribution of the Somatosensory System to Speech Perceptual Processing Aim 3

Yale University1 个研究点 分布在 1 个国家实际入组 30 人开始时间: 2019年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
30
试验地点
1
主要终点
Mean Change in Perception Judgement

研究概览

简要总结

These studies test the hypothesis that the repeated pairing of somatosensory inputs with speech sounds, such as occurs during speech motor learning, results in changes to the perceptual classification of speech sounds.

详细描述

This study will assess changes to the perceptual classification of speech sounds that are related to repeated pairing of somatosensory and auditory inputs (as would occur during speech motor learning). Before and after the training, base-line and post-training auditory perceptual performance will be examined in the absence of somatosensory stimulation, in order to evaluate the effects of the pairing on speech perception. Perceptual classification will be assessed on a 7 point continuum.

研究设计

研究类型
干预性
分配方式
随机
干预模型
平行分组
主要目的
基础科学
盲法
开放(无盲法)

入排标准

年龄范围
21 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • right handed adults
  • no known physical or neurological abnormalities

排除标准

  • patients with:
  • cardiac pacemaker
  • surgical clips or values on the heart
  • implants
  • metal or metallic fragments in any part of the body
  • pregnancy
  • claustrophobia
  • a personal or family history of epilepsy
  • currently taking antipsychotic drugs
  • currently taking antidepressant drugs
  • currently taking antianxiety drugs.

研究组 & 干预措施

Perceptual Judgement with Skin Stretch

Experimental

Perceptual Judgement with Skin Stretch

干预措施: Perceptual Classification of Speech Sounds (Behavioral)

Perceptual Judgement with Skin Stretch

Experimental

Perceptual Judgement with Skin Stretch

干预措施: Facial Skin Stretch (Behavioral)

Perceptual Judgement Control without Skin Stretch

Experimental

Perceptual Judgement Control without Skin Stretch

干预措施: Perceptual Classification of Speech Sounds (Behavioral)

方案终点

主要结局

Mean Change in Perception Judgement

时间窗: Baseline and at the end of training (30 minute session)

Change in perceptual threshold of which words participants heard when presented with different options on a synthetic acoustic 7 point interval scale continuum. Higher means indicate a greater change in auditory perception following the pairing of sounds and facial skin stretch. Score range 0-7

Speech Motor Learning

时间窗: Performance as measured at the end of learning (30 minute session)

Learning is assessed as the change in speech sounds (speech formant frequencies) on a 0 to 100 scale.

Speech Perception

时间窗: Perception is evaluated prior to and after perceptual training (30 minute session)

Auditory speech perception evaluates auditory classification and is assessed on a 0 to 100 scale. All conditions of skin stretch involve the same speech perception task.

次要结局

未报告次要终点

试验结果

结果已于 2026-09-28 在 ClinicalTrials.gov 公示。 在 ClinicalTrials.gov 查看

受试者流程

入组 30 人 · 完成 30 人

主要终点

Mean Change in Perception Judgement

score on a scale · Standard Error · 时间窗: Baseline and at the end of training (30 minute session)

Mean Change in Perception Judgement
Perceptual Judgement With Skin Stretch (n=15)Perceptual Judgement Control Without Skin Stretch (n=15)
0.163 (0.040)0.023 (0.058)

安全性

安全性
组别严重不良事件死亡
Perceptual Judgement With Skin Stretch0 / 150 / 15
Perceptual Judgement Control Without Skin Stretch0 / 150 / 15

数值为申办方在 ClinicalTrials.gov 公示的原始数据,未经重新计算;括号内为公示的离散度(如 95% 置信区间)。

研究者

申办方类型
其他
责任方
申办方

研究点 (1)

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标识符

NCT 编号
NCT04818021
其他研究编号
2000025475_b, R01DC017439

日期

首次提交
(5年前)
首次发布
(5年前)
主要完成日期
(去年)
研究完成日期
(去年)
最近核实
(29天前)
最近更新
(前天)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
否
是否有结果
是

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