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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06161857
Other study ID # 8537
Secondary ID 32889
Status Recruiting
Phase
First received
Last updated
Start date December 18, 2023
Est. completion date June 2024

Study information

Verified date February 2024
Source Cardiff and Vale University Health Board
Contact Eirwin Chief Investigator
Phone 02921 843179
Email Eirwen.jones@wales.nhs.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date June 2024
Est. primary completion date February 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United Kingdom Cardiff and Value University Health Board Cardiff

Sponsors (2)

Lead Sponsor Collaborator
Cardiff and Vale University Health Board University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
See also
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Active, not recruiting NCT06176625 - Sight and Hearing Investigation Into Effects on Delirium N/A