High Frequency ABR

Auditory Brainstem Response Thresholds at 6 and 8KHz in Adults With Normal Hearing and Sensorineural Hearing Loss

This study is looking at a method called 'ABR', which measures the electrical activity in the brain (brain waves) when we hear sounds. This study will look at the electrical activity in participants brains in response to high-pitched sounds. First, the investigators will find the quietest sounds the participants can hear. Then the investigators will use 'ABR' to measure the quietest sounds that trigger electrical activity in participants brains'. This is to find out if there is a difference between the quietest sounds participants can hear, and the quietest sounds that trigger these brain waves. We are also interested in finding out if having a hearing loss affects this.

Study Overview

• Status: Recruiting
• Conditions: Hearing Loss, High-Frequency
• Intervention / Treatment: Other: No intervention

Detailed Description

The most common way of measuring how good someone's hearing is, is to play them sounds at different levels and ask them to respond when they can hear it, for example, by pressing a button when they hear a sound. However, some people such as young children and people with learning disabilities can't do this. So, we may use the ABR technique instead. However, there are usually differences between ABR thresholds (the quietest level of sound needed to trigger an electrical response in the brain) and behavioural hearing level thresholds (the quietest level sound is perceived). If we know what this difference usually is, we can use ABR to work out how good someone's hearing is. We can already do this for most of the important pitches (aka frequencies) of sound, as typically experienced in the muffled sound in telephones. But we do not know the difference between ABR and behavioural thresholds for high-pitched sounds that help make hearing crisper. So, that is what this study is trying to find out.

To do this we need people with different hearing levels to participate in our study. Including people with normal hearing and people with a hearing loss. We aim to recruit nearly 40 people in total with a range of different hearing levels.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Eirwin Chief Investigator; Phone Number: 02921 843179; Email: Eirwen.jones@wales.nhs.uk
• Study Contact Backup: Name: Emma Principle Investigator; Phone Number: 07594192052; Email: kelly.choi-2@postgrad.manchester.ac.uk

Study Locations

• United Kingdom
  • Cardiff, United Kingdom
    • Recruiting
    • Cardiff and Value University Health Board
    • Contact: Research and Development

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

This study needs a range of participants with different hearing levels.

Description

Inclusion Criteria:

• Participant is able and willing to give informed consent.
• Participant is over 18.
• Hearing in the test ear of ≤90dBSPL at 6 kHz and 8 kHz in PTA
• Able and willing to perform PTA reliably.
• Able and willing to sit still comfortably for the duration of an ABR.

Exclusion Criteria:

• Any conductive element to hearing loss (air-bone gap on PTA of >10dB).
• Occluding wax, TM perforations or ear infections (on otoscopy)
• CI or BAHA user
• Abnormal outer of middle ear

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal Hearing Group; Participants with hearing levels of 20dBHL or better at 6 and 8kHz frequencies of sound	Other: No intervention; There is no intervention this is an observational study to develop a diagnostic test
Mild Hearing Loss Group; Participants with hearing levels of 25-40dBHL at 6 and 8kHz frequencies of sound	Other: No intervention; There is no intervention this is an observational study to develop a diagnostic test
Moderate Hearing Loss Group; Participants with hearing levels of 45-70dBHL at 6 and 8kHz frequencies of sound	Other: No intervention; There is no intervention this is an observational study to develop a diagnostic test
Severe Hearing Loss Group; Participants with hearing levels of 75- 90dBHL at 6 and 8kHz frequencies of sound	Other: No intervention; There is no intervention this is an observational study to develop a diagnostic test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between ABR and PTA thresholds	Compare ABR thresholds to PTA thresholds at 6 and 8 kHz in normal hearing adults and adults with sensorineural hearing loss.	through study completion, 4-5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of participants hearing level on ABR-PTA threshold differences	Analyse the effect of hearing level on ABR-PTA threshold differences.	through study completion, 4-5 months

Collaborators and Investigators

• Sponsor: Cardiff and Vale University Health Board
• Collaborators: University of Manchester

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, High-Frequency; Deafness
• Other Study ID Numbers: 8537 (CTEP); 32889 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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