Optimisation of Hearing Aid Fitting

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03279367
• Other study ID #: 30123
• Status: Completed
• Start date: December 22, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: July 2021
• Source: University of Southampton
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 30, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Congenital Abnormalities
• Deafness
• Hearing Abnormality
• Hearing Loss

Intervention

Diagnostic Test:
• Objective speech response detection
Changes in brain activity when a speech stimulus is presented will be measured using electro-encephalography (EEG)

Locations

Country	Name	City	State
United Kingdom	Royal Berkshire NHS Foundation Trust	Reading	Berkshire

Sponsors (5)

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

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View Citation

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. — View Citation

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: 10.33 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response detection	Detection success rate and time for obtaining a brain response to the sound stimuli.	Immediate
Secondary	Improved statistical test	Hotelling's T2 test to objectively determine the presence of a response compared to background noise.	Immediate
Secondary	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.	Immediate