Optimisation of Hearing Aid Fitting

Completed

• Conditions: Hearing Loss; Hearing Abnormality
• Interventions: Diagnostic Test: Objective speech response detection

• Registration Number: NCT03279367
• Lead Sponsor: University of Southampton

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.

Study Timeline

• Study First Submitted: 2017-09-08
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-12
• Study Start: 2017-12-22
• Primary Completion: 2018-09-01
• Study Completion: 2018-09-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-24
• Last Update Posted: 2021-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hearing Impaired	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.

Primary Outcome Measures

Name	Time	Method
Objective response detection	Immediate	Detection success rate and time for obtaining a brain response to the sound stimuli.

Secondary Outcome Measures

Name	Time	Method
Stimulus reconstruction	Immediate	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.
Improved statistical test	Immediate	Hotelling's T2 test to objectively determine the presence of a response compared to background noise.

Trial Locations

Locations (1)

Royal Berkshire NHS Foundation Trust; 🇬🇧 Reading, Berkshire, United Kingdom