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临床试验/NCT06022367
NCT06022367已完成不适用

An Investigation Into the Effect of the Head Raise and Head Turn Activation Techniques on Quality of Elicited Cervical Vestibular Evoked Myogenic Potentials (cVEMPs)

Liverpool University Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
cVEMP signal quality

研究概览

简要总结

This study will investigate two different techniques used for eliciting sternocleidomastoid (SCM) muscle contraction. Sustained contraction of the SCM muscle is necessary for accurate recording of cervical vestibular evoked myogenic potentials (cVEMPs). These responses are used clinically to assess the function of structures within the vestibular system.

The British Society of Audiology (BSA) guidelines recommend the head turn and head raise techniques as effective methods for eliciting SCM contraction. However, they do not recommend which technique to employ, leaving that to the discretion of the clinician. The purpose of this study is to determine which activation technique to recommend in the local standard operating procedure on cVEMP testing developed by the Audiology and Vestibular Function Testing service based at the Royal Liverpool University Hospital.

Healthy volunteers will be recruited to the study. The study will be conducted at the Royal Liverpool University Hospital, Liverpool, UK.

The participants will each be invited to attend one appointment in which they will undergo cVEMP testing, performed using each activation technique in turn. After testing the participants will be asked to complete a questionnaire in which they will comment on their experience of performing each technique and assign each a tolerability rating.

研究设计

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

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

  • Participant is willing and able to give informed consent for participation in the study.
  • Able (in the Investigators opinion) and willing to comply with all study requirements.
  • Male, female or non-binary, aged 18-60 years old.

排除标准

  • Pain, sore areas, broken skin at the sites of contact with skin electrodes
  • Devices, e.g. cochlear implants, which may cause electrical interference
  • Exclusion criteria to cVEMP procedure :
  • Conductive hearing loss of middle ear origin
  • Sensitivity to sounds e.g. tinnitus, hyperacusis etc.
  • Cervical spine problems
  • Exclusion criteria to tympanometry procedure :
  • Occlusion of the external auditory canal
  • Otorrhoea
  • Excessive wax
  • Within two months of ear surgery

结局指标

主要结局

cVEMP signal quality

时间窗: During single 1.5 hour appointment

Ratio of cVEMP signal power to background noise power

次要结局

  • cVEMP signal amplitude(During single 1.5 hour appointment)
  • Activation technique tolerability rating(During single 1.5 hour appointment)
  • Activation technique tolerability subjective feedback(During single 1.5 hour appointment)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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