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Completed

NCT Number: NCT03279367

Optimisation of Hearing Aid Fitting

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.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Berkshire NHS Foundation Trust

Reading, Berkshire, RG15LE, United Kingdom

About this study

The research questions addressed are as follows

  • Are speech-evoked objective brain responses sensitive to hearing aid amplification?
  • Are speech-evoked brain responses sensitive to distortions in speech and can hearing aid amplification resolve issues with brain responses to distorted speech?
  • Which tests are optimal for detection of objective brain responses to speech?
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Objective speech response detection

Diagnostic Test

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

Primary outcomes

  1. Objective response detection

    Time frame: Immediate

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

Secondary outcomes

  1. Improved statistical test

    Time frame: Immediate

    Hotelling's T2 test to objectively determine the presence of a response compared to background noise.

  2. Stimulus reconstruction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Southampton

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 12, 2017
Registry last updated
Jul 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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