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| Name | Class |
|---|---|
| Royal Berkshire NHS Foundation Trust | OTHER_GOV |
| University of Manchester | OTHER |
| Imperial College London | OTHER |
| Engineering and Physical Sciences Research Council, UK |
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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.
The research questions addressed are as follows
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Objective speech response detection | Diagnostic Test | Changes in brain activity when a speech stimulus is presented will be measured using electro-encephalography (EEG) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response detection | Detection success rate and time for obtaining a brain response to the sound stimuli. | Immediate |
| Measure | Description | Time Frame |
|---|---|---|
| Improved statistical test | Hotelling's T2 test to objectively determine the presence of a response compared to background noise. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Steven L Bell, Dr | University of Southampton | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Berkshire NHS Foundation Trust | Reading | Berkshire | RG15LE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32317951 | Result | 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. | |
| 30675827 | Result |
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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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 14, 2017 | Sep 7, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 15, 2017 | Sep 7, 2017 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| OTHER |
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| Immediate |
| Vanheusden 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. |
| 29757799 | Result | Vanheusden 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. |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |