High Frequency ABR

NCT ID: NCT06161857

Last Updated: 2024-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-18

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Hearing Loss, High-Frequency

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal Hearing Group

Participants with hearing levels of 20dBHL or better at 6 and 8kHz frequencies of sound

No intervention

Intervention Type OTHER

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

No intervention

Intervention Type OTHER

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

No intervention

Intervention Type OTHER

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

No intervention

Intervention Type OTHER

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

Interventions

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No intervention

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Manchester

OTHER

Sponsor Role collaborator

Cardiff and Vale University Health Board

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cardiff and Value University Health Board

Cardiff, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Eirwin Chief Investigator

Role: CONTACT

02921 843179

Emma Principle Investigator

Role: CONTACT

07594192052

Facility Contacts

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Research and Development

Role: primary

Other Identifiers

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32889

Identifier Type: OTHER

Identifier Source: secondary_id

8537

Identifier Type: -

Identifier Source: org_study_id

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