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Optimisation of Hearing Aid Fitting

Objective Response Detection to Natural Speech Stimuli for Optimisation of Hearing Aid Fitting Evaluation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03279367
Enrollment
20
Registered
2017-09-12
Start date
2017-12-22
Completion date
2018-09-30
Last updated
2021-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Abnormality, Hearing Loss

Keywords

Hearing Loss, Hearing Abnormality

Brief 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 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 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.

Interventions

DIAGNOSTIC_TESTObjective speech response detection

Changes in brain activity when a speech stimulus is presented will be measured using electro-encephalography (EEG)

Sponsors

Royal Berkshire NHS Foundation Trust
CollaboratorOTHER_GOV
University of Manchester
CollaboratorOTHER
Imperial College London
CollaboratorOTHER
Engineering and Physical Sciences Research Council, UK
CollaboratorOTHER
University of Southampton
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Objective response detectionImmediateDetection success rate and time for obtaining a brain response to the sound stimuli.

Secondary

MeasureTime frameDescription
Improved statistical testImmediateHotelling's T2 test to objectively determine the presence of a response compared to background noise.
Stimulus reconstructionImmediateCorrelation 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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026