Optimisation of Hearing Aid Fitting

NCT ID: NCT03279367

Last Updated: 2021-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-22

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hearing Loss Hearing Abnormality

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Objective speech response detection

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Objective speech response detection

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Berkshire NHS Foundation Trust

OTHER_GOV

Sponsor Role collaborator

University of Manchester

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role collaborator

Engineering and Physical Sciences Research Council, UK

OTHER

Sponsor Role collaborator

University of Southampton

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven L Bell, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Southampton

Locations

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Royal Berkshire NHS Foundation Trust

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 32317951 (View on PubMed)

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.

Reference Type RESULT
PMID: 30675827 (View on PubMed)

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.

Reference Type RESULT
PMID: 29757799 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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30123

Identifier Type: -

Identifier Source: org_study_id

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