Activation Technique in cVEMPs

Not Applicable

Completed

• Conditions: Activation Technique in cVEMP Testing
• Interventions: Diagnostic Test: Head Turn Activation Technique; Diagnostic Test: Head Raise Activation Technique

• Registration Number: NCT06022367
• Lead Sponsor: Liverpool University Hospitals NHS Foundation Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-11-23
• Study Start: 2022-12-15
• Primary Completion: 2023-02-24
• Study Completion: 2023-02-24
• Study First Submitted QC: 2023-08-31
• Last Update Submitted: 2023-08-31
• Study First Posted: 2023-09-01
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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
• Otalgia
• Excessive wax
• Within two months of ear surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Turn-Raise Sequence	Head Turn Activation Technique	Participant performs cVEMP twice using the head turn activation technique followed by the head raise activation technique.
Raise-Turn Sequence	Head Turn Activation Technique	Participant performs cVEMP twice using the head raise activation technique followed by the head turn activation technique.
Raise-Turn Sequence	Head Raise Activation Technique	Participant performs cVEMP twice using the head raise activation technique followed by the head turn activation technique.
Turn-Raise Sequence	Head Raise Activation Technique	Participant performs cVEMP twice using the head turn activation technique followed by the head raise activation technique.

Primary Outcome Measures

Name	Time	Method
cVEMP signal quality	During single 1.5 hour appointment	Ratio of cVEMP signal power to background noise power

Secondary Outcome Measures

Name	Time	Method
cVEMP signal amplitude	During single 1.5 hour appointment	P1-N1 amplitude measured from the P1 to N1 peaks
Activation technique tolerability rating	During single 1.5 hour appointment	Participant reported tolerability will be scored on a four-point LIKERT scale ranging from 1 (highly intolerable) to 4 (highly tolerable)
Activation technique tolerability subjective feedback	During single 1.5 hour appointment	Participant reported concerns shared through a post-test questionnaire

Trial Locations

Locations (1)

Liverpool University Hospitals NHS Foundation Trust; 🇬🇧 Liverpool, United Kingdom