Hearing LossNCT03279367
Optimisation of Hearing Aid Fitting
An observational study of Hearing Loss and Hearing Abnormality, run by University of Southampton at 1 site in United Kingdom.
Trial summary
This study aims to explore if objective brain responses to speech stimuli (words and running speech) can be used to evaluate hearing aid fitting in adults. Objective brain responses would be beneficial, as they could be used to evaluate hearing with people who are incapable or unwilling to provide subjective… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hearing Loss, Hearing Abnormality
- What is being tested?
- Objective speech response detection
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Dec 2017to 30 Sep 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be included if they are between 18 and 70 years old, are native English speakers and have mild to moderate hearing loss in their better ear measured using current clinical standards. They will be identified from their medical records of the Royal Berkshire NHS Foundation Trust by the Co-Investigators who are trained and qualified clinical audiologists at the Trust. Subjects will be routine hearing aid users.
Who may be able to join
- Subjects are between 18 and 70 years old
- Native English speakers
- Have mild to moderate hearing loss in their better ear measured using current clinical standards
- Routine hearing aid users
Who cannot join
- Clinical observation indicates the presence of ear infections or an occluded ear canal on the day of testing
- Subjects with recent ear surgery (within a month before the day of testing)
- Subjects who are taking substances that could affect brain responses (e.g. medication for the treatment of depression)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Berkshire NHS Foundation Trust
Reading, Berkshire, RG15LE
About this study
Official title: Objective Response Detection to Natural Speech Stimuli for Optimisation of Hearing Aid Fitting Evaluation
This study aims to explore if objective brain responses to speech stimuli (words and running speech) can be used to evaluate hearing aid fitting in adults. Objective brain responses would be beneficial, as they could be used to evaluate hearing with people who are incapable or unwilling to provide subjective responses. The study aims to determine if EEG responses to speech sounds are sensitive to the effects of hearing aids for hearing aid users. Secondary, the study will look into the need for using speech stimuli in order to obtain more robust responses compared to current clinical standards.
Read the detailed description
The research questions addressed are as follows
- Are speech-evoked objective brain responses sensitive to hearing aid amplification?
- Are speech-evoked brain responses sensitive to distortions in speech and can hearing aid amplification resolve issues with brain responses to distorted speech?
- Which tests are optimal for detection of objective brain responses to speech?
- Are realistic speech stimuli (words or running speech) able to robustly detect brain responses compared to current clinical standards (clicks and tones)? The study will be carried out on a group of mildly to moderately hearing impaired subjects between the age of 18 and 70. Subjects will be recruited from the Royal Berkshire NHS Foundation Trust, where the research will be conducted. Participants will have their hearing function and hearing aid fitting checked as described in the design and methodology section of this proposal. During the experiment, participants will be asked to listen to speech sounds presented from a loudspeaker at comfortable listening levels. The responses will be measured with the participant wearing and not wearing hearing aids. Additionally, participants will perform a behavioural task for perception of speech. Participants will be asked to attend 2 sessions of 2 hours. Data collection will run over 1 year.
- Conditions
- Hearing Loss, Hearing Abnormality
- Being tested
- Objective speech response detection
- Keywords
- Hearing Loss, Hearing Abnormality
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Objective speech response detectionDiagnostic test
Changes in brain activity when a speech stimulus is presented will be measured using electro-encephalography (EEG)
| Study group | Role | What they receive |
|---|---|---|
| Hearing Impaired | Participants will be asked to wear an electro-encephalography (EEG) cap for measurement of brain activity whilst listening to speech stimuli. The speech stimuli will be presented through a loudspeaker positioned 1 meter in front of the participant. Participants will be asked to listen to the speech stimuli when using and without using their hearing aid. They will be asked to pay attention to the speech stimuli. This will be assured by asking them to answer questions related to the speech stimulus at random intervals. Subjects will also go through standard clinical procedures for assessing their hearing function and hearing aid setup. Receives: Diagnostic Test: Objective speech response detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response detection
Detection success rate and time for obtaining a brain response to the sound stimuli.
Measured: Immediate
Secondary outcomes (2)
Improved statistical test
Hotelling's T2 test to objectively determine the presence of a response compared to background noise.
Measured: Immediate
Stimulus reconstruction
Correlation test to determine the accuracy of the estimated speech stimulus using the decoder compared to the presented speech stimulus for running speech.
Detection of auditory brainstem and auditory steady state potential characteristic peaks and troughs for responses to click and tone stimuli, respectively.
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start22 Dec 2017
- Primary completion1 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Berkshire NHS Foundation Trust, University of Manchester, Imperial College London, Engineering and Physical Sciences Research Council, UK
- Responsible party
- Sponsor
- Investigators
- Steven L Bell, Dr, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279367
- Sponsor's protocol ID
- 30123
- Status last verified
- Jul 2021
- First submitted
- 8 Sep 2017
- Last updated
- 30 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised data will be collected and stored in Pure/ePrints at the University of Southampton along with a metadata file describing the procedure and providing participant demographics such as age and gender. Anonymised data will also be stored on password-protected University computers and backed up on password-protected hard drives. Anonymised data will be kept available for public access (for research and teaching purposes) under guidelines of the University of Southampton for at least 10 years. Clear information regarding the storage and possible reuse of anonymized data will be given to the participant prior to the experiment. Participants will have the possibility to opt out of this data sharing policy.
Publications
Vanheusden FJ, Kegler M, Ireland K, Georga C, Simpson DM, Reichenbach T, Bell SL. Hearing Aids Do Not Alter Cortical Entrainment to Speech at Audible Levels in Mild-to-Moderately Hearing-Impaired Subjects. Front Hum Neurosci. 2020 Apr 3;14:109. doi: 10.3389/fnhum.2020.00109. eCollection 2020.
PubMed 32317951Vanheusden FJ, Chesnaye MA, Simpson DM, Bell SL. Envelope frequency following responses are stronger for high-pass than low-pass filtered vowels. Int J Audiol. 2019 Jun;58(6):355-362. doi: 10.1080/14992027.2018.1562243. Epub 2019 Jan 24.
PubMed 30675827Vanheusden FJ, Bell SL, Chesnaye MA, Simpson DM. Improved Detection of Vowel Envelope Frequency Following Responses Using Hotelling's T2 Analysis. Ear Hear. 2019 Jan/Feb;40(1):116-127. doi: 10.1097/AUD.0000000000000598.
PubMed 29757799
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Response Detection to Natural Speech Stimuli for Optimisation of Hearing Aid Fitting Evaluation
- ClinicalTrials.gov ID
- NCT03279367
- Acronym / sponsor ID
- 30123
- Conditions
- Hearing Loss, Hearing Abnormality
- Keywords
- Hearing Loss, Hearing Abnormality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- Royal Berkshire NHS Foundation Trust, University of Manchester, Imperial College London, Engineering and Physical Sciences Research Council, UK
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 12 Sep 2017 (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 aims to explore if objective brain responses to speech stimuli (words and running speech) can be used to evaluate hearing aid fitting in adults. Objective brain responses would be beneficial, as they could be used to evaluate hearing with people who are incapable or unwilling to provide subjective responses. The study aims to determine if EEG responses to speech sounds are sensitive to the effects of hearing aids for hearing aid users. Secondary, the study will look into the need for using speech stimuli in order to obtain more robust responses compared to current clinical standards.
Detailed description
The research questions addressed are as follows
- Are speech-evoked objective brain responses sensitive to hearing aid amplification?
- Are speech-evoked brain responses sensitive to distortions in speech and can hearing aid amplification resolve issues with brain responses to distorted speech?
- Which tests are optimal for detection of objective brain responses to speech?
- Are realistic speech stimuli (words or running speech) able to robustly detect brain responses compared to current clinical standards (clicks and tones)? The study will be carried out on a group of mildly to moderately hearing impaired subjects between the age of 18 and 70. Subjects will be recruited from the Royal Berkshire NHS Foundation Trust, where the research will be conducted. Participants will have their hearing function and hearing aid fitting checked as described in the design and methodology section of this proposal. During the experiment, participants will be asked to listen to speech sounds presented from a loudspeaker at comfortable listening levels. The responses will be measured with the participant wearing and not wearing hearing aids. Additionally, participants will perform a behavioural task for perception of speech. Participants will be asked to attend 2 sessions of 2 hours. Data collection will run over 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hearing Impaired | – | Diagnostic Test: Objective speech response detectionParticipants will be asked to wear an electro-encephalography (EEG) cap for measurement of brain activity whilst listening to speech stimuli. The speech stimuli will be presented through a loudspeaker positioned 1 meter in front of the participant. Participants will be asked to listen to the speech stimuli when using and without using their hearing aid. They will be asked to pay attention to the speech stimuli. This will be assured by asking them to answer questions related to the speech stimulus at random intervals. Subjects will also go through standard clinical procedures for assessing their hearing function and hearing aid setup. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be included if they are between 18 and 70 years old, are native English speakers and have mild to moderate hearing loss in their better ear measured using current clinical standards. They will be identified from their medical records of the Royal Berkshire NHS Foundation Trust by the Co-Investigators who are trained and qualified clinical audiologists at the Trust. Subjects will be routine hearing aid users.
Key inclusion criteria (4 listed)
- Subjects are between 18 and 70 years old
- Native English speakers
- Have mild to moderate hearing loss in their better ear measured using current clinical standards
- Routine hearing aid users
Key exclusion criteria (3 listed)
- Clinical observation indicates the presence of ear infections or an occluded ear canal on the day of testing
- Subjects with recent ear surgery (within a month before the day of testing)
- Subjects who are taking substances that could affect brain responses (e.g. medication for the treatment of depression)
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 |
|---|---|---|
| Objective speech response detectionChanges in brain activity when a speech stimulus is presented will be measured using electro-encephalography (EEG) | Diagnostic test | Hearing Impaired |
Primary outcome
Objective response detection
Time frame: Immediate
Detection success rate and time for obtaining a brain response to the sound stimuli.
2 secondary outcomes
Improved statistical test
Time frame: Immediate
Stimulus reconstruction
Time frame: Immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Results publication: PubMed 32317951Vanheusden FJ, Kegler M, Ireland K, Georga C, Simpson DM, Reichenbach T, Bell SL. Hearing Aids Do Not Alter Cortical Entrainment to Speech at Audible Levels in Mild-to-Moderately Hearing-Impaired Subjects. Front Hum Neurosci. 2020 Apr 3;14:109. doi: 10.3389/fnhum.2020.00109. eCollection 2020.
- Results publication: PubMed 30675827Vanheusden FJ, Chesnaye MA, Simpson DM, Bell SL. Envelope frequency following responses are stronger for high-pass than low-pass filtered vowels. Int J Audiol. 2019 Jun;58(6):355-362. doi: 10.1080/14992027.2018.1562243. Epub 2019 Jan 24.
- Results publication: PubMed 29757799Vanheusden FJ, Bell SL, Chesnaye MA, Simpson DM. Improved Detection of Vowel Envelope Frequency Following Responses Using Hotelling's T2 Analysis. Ear Hear. 2019 Jan/Feb;40(1):116-127. doi: 10.1097/AUD.0000000000000598.
- Individual participant dataSharing planned: No. Anonymised data will be collected and stored in Pure/ePrints at the University of Southampton along with a metadata file describing the procedure and providing participant demographics such as age and gender. Anonymised data will also be stored on password-protected University computers and backed up on password-protected hard drives. Anonymised data will be kept available for public access (for research and teaching purposes) under guidelines of the University of Southampton for at least 10 years. Clear information regarding the storage and possible reuse of anonymized data will be given to the participant prior to the experiment. Participants will have the possibility to opt out of this data sharing policy.
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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.
Steven L Bell, Dr principal investigator
University of Southampton
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 and Hearing Abnormality, run by University of Southampton 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 30 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response detection (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03279367, which also lists 3 linked publications.
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 30 Jul 2021; AzTrials last refreshed its copy on 27 Oct 2026.