Activation Technique in cVEMPs (ACTIVE)

Liverpool University Hospitals NHS Foundation Trust

Status: Completed

Conditions: Activation Technique in cVEMP Testing

Treatments: Diagnostic Test: Head Raise Activation Technique; Diagnostic Test: Head Turn Activation Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06022367

LHS0016

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Raise-Turn Sequence

Experimental group

Description:

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

Treatment:

Diagnostic Test: Head Raise Activation Technique

Diagnostic Test: Head Turn Activation Technique

Turn-Raise Sequence

Experimental group

Description:

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

Treatment:

Diagnostic Test: Head Raise Activation Technique

Diagnostic Test: Head Turn Activation Technique