Activation Technique in cVEMPs (ACTIVE)

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

Study Overview

• Status: Completed
• Conditions: Activation Technique in cVEMP Testing
• Intervention / Treatment: Diagnostic test: Head Turn Activation Technique; Diagnostic test: Head Raise Activation Technique

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Liverpool, United Kingdom, L7 8XP
    • Liverpool University Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Raise-Turn Sequence; Participant performs cVEMP twice using the head raise activation technique followed by the head turn activation technique.	Diagnostic test: 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.; 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.
Experimental: Turn-Raise Sequence; Participant performs cVEMP twice using the head turn activation technique followed by the head raise activation technique.	Diagnostic test: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cVEMP signal quality	Ratio of cVEMP signal power to background noise power	During single 1.5 hour appointment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Liverpool University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Actual): February 24, 2023
• Study Completion (Actual): February 24, 2023

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 1, 2023

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: LHS0016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No