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Completed

NCT Number: NCT06022367

Activation Technique in cVEMPs

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.

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Key information

Conditions

Activation Technique in cVEMP Testing

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liverpool University Hospitals NHS Foundation Trust

Liverpool, L7 8XP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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

Treatment and study plan

Head Turn Activation Technique

Diagnostic Test

Participant sat upright with head turned to the side through 45 degrees. They are presented with an auditory stimulus delivered using insert earphones and their cVEMP response is recorded using skin electrodes.

Head Raise Activation Technique

Diagnostic Test

Participant assumes caloric test position (30 degrees from horizontal) with head raised. Participant is presented with an auditory stimulus delivered using insert earphones and their cVEMP response is recorded using skin electrodes.

Primary outcomes

  1. cVEMP signal quality

    Time frame: During single 1.5 hour appointment

    Ratio of cVEMP signal power to background noise power

Secondary outcomes

  1. cVEMP signal amplitude

    Time frame: During single 1.5 hour appointment

    P1-N1 amplitude measured from the P1 to N1 peaks

  2. Activation technique tolerability rating

    Time frame: 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)

  3. Activation technique tolerability subjective feedback

    Time frame: During single 1.5 hour appointment

    Participant reported concerns shared through a post-test questionnaire

Sponsors and collaborators

Lead sponsor

Liverpool University Hospitals NHS Foundation Trust

Other Gov

Registry information

Official study title

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

Acronym: ACTIVE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 1, 2023
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.