Clinical trial NCT06022367: Activation Technique in cVEMPs
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Activation Technique in cVEMP Testing
Lead sponsor: Liverpool University Hospitals NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2023-09-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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

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

Primary outcomes:
measure: cVEMP signal quality
timeFrame: During single 1.5 hour appointment
Secondary outcomes:
measure: cVEMP signal amplitude
timeFrame: During single 1.5 hour appointment
measure: Activation technique tolerability rating
timeFrame: During single 1.5 hour appointment
measure: Activation technique tolerability subjective feedback
timeFrame: During single 1.5 hour appointment
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust
Study officials:
References: