Optimisation of Hearing Aid Fitting

NCT03279367 | Completed

• 1 other identifier: 30123
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss; Hearing Abnormality

Keywords

Hearing Loss; Hearing Abnormality

Outcome Measures

Primary Outcomes (1)

• Objective response detection

  Detection success rate and time for obtaining a brain response to the sound stimuli.

  Immediate

Secondary Outcomes (2)

• Improved statistical test

  Immediate

• Stimulus reconstruction

  Immediate

Study Arms (1)

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.

Diagnostic Test: Objective speech response detection

Interventions

Objective speech response detection DIAGNOSTIC_TEST

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

Hearing Impaired

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Imperial College London: collaborator
• University of Southampton: lead
• Royal Berkshire NHS Foundation Trust: collaborator
• University of Manchester: collaborator
• Engineering and Physical Sciences Research Council, UK: collaborator

Study Sites (1)

Royal Berkshire NHS Foundation Trust

Reading, Berkshire, RG15LE, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 32317951 RESULT

• 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.

  PMID: 30675827 RESULT

• 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.

  PMID: 29757799 RESULT

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Steven L Bell, Dr

  University of Southampton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 12, 2017
• Study Start: December 22, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 30, 2018
• Last Updated: July 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)