Activation Technique in cVEMPs

NCT ID: NCT06022367

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2023-02-24

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.

Conditions

Activation Technique in cVEMP Testing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Raise-Turn Sequence

Participant performs cVEMP twice using the head raise activation technique followed by the head turn activation technique.

Group Type: EXPERIMENTAL

Head Turn Activation Technique

Intervention Type: 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

Intervention Type: 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.

Turn-Raise Sequence

Participant performs cVEMP twice using the head turn activation technique followed by the head raise activation technique.

Group Type: EXPERIMENTAL

Head Turn Activation Technique

Intervention Type: 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

Intervention Type: 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.

Interventions

Head Turn Activation Technique

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.

Intervention Type: DIAGNOSTIC_TEST

Head Raise Activation Technique

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Conductive hearing loss of middle ear origin
• Sensitivity to sounds e.g. tinnitus, hyperacusis etc.
• Cervical spine problems

• Occlusion of the external auditory canal
• Otorrhoea
• Otalgia
• Excessive wax
• Within two months of ear surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Liverpool University Hospitals NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Liverpool University Hospitals NHS Foundation Trust

Liverpool, , United Kingdom

Countries

United Kingdom

Other Identifiers

LHS0016

Identifier Type: -

Identifier Source: org_study_id