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临床试验/NCT04766658
NCT04766658已完成不适用

Gargle Phonation in Individuals With Muscle Tension Dysphonia

Mayo Clinic4 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年1月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
36
试验地点
4
主要终点
Rating of Effort Baseline

研究概览

简要总结

The purpose of this study is to assess subjects with muscle tension dysphonia for perceived effort and acoustic effects of gargle phonation compared to baseline and a sham water swallow.

详细描述

This study assesses perceived effort following baseline talking, water swallows and gargle phonation. In addition to perceived effort, acoustic and perceptual analyses will be conducted on the recorded voice samples using vowel sounds, the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) and Hearing in Noise Sentences (HINT).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients must have a primary or secondary muscle tension dysphonia based clinical assessment with a Mayo clinic speech language pathologist or other Mayo Clinic otolaryngology care provider in Rochester or Phoenix/Scottsdale locations.
  • Age 18 through
  • Able to provide informed consent.

排除标准

  • Anyone not meeting inclusion criteria.
  • Anyone unable or unwilling to provide informed consent.
  • Anyone unable to complete questionnaires or participate in voice recording.
  • Anyone with severe neurological voice or speech disorders.
  • Moderate or severe dysphagia for thin liquids.
  • Non-English speakers (English as a second language may be included).
  • Extensive laryngeal surgery or other surgery or medical condition that may significantly alter the motor or sensory aspects of the larynx.

结局指标

主要结局

Rating of Effort Baseline

时间窗: Baseline

Measured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort.

Rating of Effort Post Swallow

时间窗: After water swallow intervention, approximately 5 minutes

Measured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort.

Rating of Effort Post Gargle

时间窗: After gargle phonation intervention, approximately 5 minutes

Measured using patient self-reported Borg effort scale where 0=no vocal effort and 10=maximum vocal effort.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Diana M. Orbelo

Principal Investigator

Mayo Clinic

研究点 (4)

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