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High Frequency ABR

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06161857
Enrollment
40
Registered
2023-12-08
Start date
2023-12-18
Completion date
2024-06-30
Last updated
2024-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss, High-Frequency

Brief summary

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.

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.

Interventions

OTHERNo intervention

There is no intervention this is an observational study to develop a diagnostic test

Sponsors

University of Manchester
CollaboratorOTHER
Cardiff and Vale University Health Board
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Difference between ABR and PTA thresholdsthrough study completion, 4-5 monthsCompare ABR thresholds to PTA thresholds at 6 and 8 kHz in normal hearing adults and adults with sensorineural hearing loss.

Secondary

MeasureTime frameDescription
Effect of participants hearing level on ABR-PTA threshold differencesthrough study completion, 4-5 monthsAnalyse the effect of hearing level on ABR-PTA threshold differences.

Countries

United Kingdom

Contacts

Primary ContactEirwin Chief Investigator
Eirwen.jones@wales.nhs.uk02921 843179
Backup ContactEmma Principle Investigator
kelly.choi-2@postgrad.manchester.ac.uk07594192052

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026