High Frequency ABR
Auditory Brainstem Response Thresholds at 6 and 8KHz in Adults With Normal Hearing and Sensorineural Hearing Loss
2 other identifiers
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2023
CompletedFirst Posted
Study publicly available on registry
December 8, 2023
CompletedStudy Start
First participant enrolled
December 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedFebruary 15, 2024
February 1, 2024
2 months
November 20, 2023
February 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Effect of participants hearing level on ABR-PTA threshold differences
through study completion, 4-5 months
Study Arms (4)
Normal Hearing Group
Participants with hearing levels of 20dBHL or better at 6 and 8kHz frequencies of sound
Mild Hearing Loss Group
Participants with hearing levels of 25-40dBHL at 6 and 8kHz frequencies of sound
Moderate Hearing Loss Group
Participants with hearing levels of 45-70dBHL at 6 and 8kHz frequencies of sound
Severe Hearing Loss Group
Participants with hearing levels of 75- 90dBHL at 6 and 8kHz frequencies of sound
Interventions
There is no intervention this is an observational study to develop a diagnostic test
Eligibility Criteria
This study needs a range of participants with different hearing levels.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cardiff and Vale University Health Boardlead
- University of Manchestercollaborator
Study Sites (1)
Cardiff and Value University Health Board
Cardiff, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2023
First Posted
December 8, 2023
Study Start
December 18, 2023
Primary Completion
February 1, 2024
Study Completion
June 1, 2024
Last Updated
February 15, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share