Objective Response Detection to Natural Speech Stimuli for Optimisation of Hearing Aid Fitting Evaluation
| Registry | NCT03279367 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 20 (Actual) |
| Sponsor | University of Southampton (Other); collaborators: Royal Berkshire NHS Foundation Trust, University of Manchester, Imperial College London, Engineering and Physical Sciences Research Council, UK |
| Conditions | Hearing Loss, Hearing Abnormality |
| Interventions | Objective speech response detection (Diagnostic test) |
| Dates | start 2017-12-22, primary completion 2018-09-01, completion 2018-09-30, first posted 2017-09-12, last updated 2021-07-30 |
| Locations | 1 site in United Kingdom |
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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
1. Are speech-evoked objective brain responses sensitive to hearing aid amplification?
2. Are speech-evoked brain responses sensitive to distortions in speech and can hearing aid amplification resolve issues with brain responses to distorted speech?
3. Which tests are optimal for detection of objective brain responses to speech?
4. 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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Hearing Impaired | Diagnostic Test: Objective speech response detection | 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. |
Sex: All, ages: 18 Years to 70 Years
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
| Facility | City | Country | Status |
|---|---|---|---|
| Royal Berkshire NHS Foundation Trust | Reading, Berkshire | United Kingdom |