Hearing Loss, High-FrequencyNCT06161857
High Frequency ABR
An observational study of Hearing Loss, High-Frequency, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, High-Frequency
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Dec 2023to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study needs a range of participants with different hearing levels.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Cardiff and Value University Health Board
Cardiff
Research and Development
About this study
Official title: 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.
Read the 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.
- Conditions
- Hearing Loss, High-Frequency
- Being tested
- No intervention
- Medical subject headings
- Hearing Loss, High-Frequency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention this is an observational study to develop a diagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Normal Hearing Group | Participants with hearing levels of 20dBHL or better at 6 and 8kHz frequencies of sound Receives: Other: No intervention | |
| Mild Hearing Loss Group | Participants with hearing levels of 25-40dBHL at 6 and 8kHz frequencies of sound Receives: Other: No intervention | |
| Moderate Hearing Loss Group | Participants with hearing levels of 45-70dBHL at 6 and 8kHz frequencies of sound Receives: Other: No intervention | |
| Severe Hearing Loss Group | Participants with hearing levels of 75- 90dBHL at 6 and 8kHz frequencies of sound Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, 4-5 months
Secondary outcomes (1)
Effect of participants hearing level on ABR-PTA threshold differences
Analyse the effect of hearing level on ABR-PTA threshold differences.
Measured: through study completion, 4-5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start18 Dec 2023
- Primary completionFeb 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, High-FrequencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Collaborators
- University of Manchester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161857
- Sponsor's protocol ID
- 8537
- Other IDs
- 32889
- Status last verified
- Feb 2024
- First submitted
- 20 Nov 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auditory Brainstem Response Thresholds at 6 and 8KHz in Adults With Normal Hearing and Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT06161857
- Acronym / sponsor ID
- 8537
- Conditions
- Hearing Loss, High-Frequency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Collaborators
- University of Manchester
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal Hearing Group | – | Other: No interventionParticipants with hearing levels of 20dBHL or better at 6 and 8kHz frequencies of sound |
| Mild Hearing Loss Group | – | Other: No interventionParticipants with hearing levels of 25-40dBHL at 6 and 8kHz frequencies of sound |
| Moderate Hearing Loss Group | – | Other: No interventionParticipants with hearing levels of 45-70dBHL at 6 and 8kHz frequencies of sound |
| Severe Hearing Loss Group | – | Other: No interventionParticipants with hearing levels of 75- 90dBHL at 6 and 8kHz frequencies of sound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study needs a range of participants with different hearing levels.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThere is no intervention this is an observational study to develop a diagnostic test | Other | Mild Hearing Loss Group, Moderate Hearing Loss Group, Normal Hearing Group, Severe Hearing Loss Group |
Primary outcome
Difference between ABR and PTA thresholds
Time frame: through study completion, 4-5 months
Compare ABR thresholds to PTA thresholds at 6 and 8 kHz in normal hearing adults and adults with sensorineural hearing loss.
1 secondary outcome
Effect of participants hearing level on ABR-PTA threshold differences
Time frame: through study completion, 4-5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, High-Frequency, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eirwin Chief Investigator (02921 843179, Eirwen.jones@wales.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between ABR and PTA thresholds (time frame: through study completion, 4-5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.