Clinical trial NCT03279367: Optimisation of Hearing Aid Fitting
Official title: Objective Response Detection to Natural Speech Stimuli for Optimisation of Hearing Aid Fitting Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Hearing Abnormality
Keywords: Hearing Loss
Hearing Abnormality
Lead sponsor: University of Southampton
Sponsor class: OTHER
Collaborators: name: Royal Berkshire NHS Foundation Trust
name: University of Manchester
name: Imperial College London
name: Engineering and Physical Sciences Research Council, UK
First posted: 2017-09-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be included if they are between 18 and 70 years old, are native English speakers and have mild to moderate hearing loss in their better ear measured using current clinical standards. They will be identified from their medical records of the Royal Berkshire NHS Foundation Trust by the Co-Investigators who are trained and qualified clinical audiologists at the Trust. Subjects will be routine hearing aid users.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Objective response detection
timeFrame: Immediate
Secondary outcomes:
measure: Improved statistical test
timeFrame: Immediate
measure: Stimulus reconstruction
timeFrame: Immediate
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Royal Berkshire NHS Foundation Trust
state: Berkshire
Study officials:
affiliation: University of Southampton
name: Steven L Bell, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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: 10.3389/fnhum.2020.00109. eCollection 2020.
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.
citation: 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.