Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
20 participants
OBSERVATIONAL
2017-12-22
2018-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces
NCT05867173
Neurophysiological Measures of Auditory Perception and Rehabilitation in Cochlear Implanted Patients
NCT02323256
Investigation of Anatomical Correlates of Speech Discrimination
NCT01781039
Cerebral Activation and Bilateral Stimulation by Cochlear Implantation in Bilateral Deaf Adults
NCT02904187
Improving Spatial Perception and Speech Understanding in Multitalker Mixtures
NCT05260307
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Changes in brain activity when a speech stimulus is presented will be measured using electro-encephalography (EEG)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Objective speech response detection
Changes in brain activity when a speech stimulus is presented will be measured using electro-encephalography (EEG)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Native English speakers
* Have mild to moderate hearing loss in their better ear measured using current clinical standards
* Routine hearing aid users
Exclusion Criteria
* 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)
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Royal Berkshire NHS Foundation Trust
OTHER_GOV
University of Manchester
OTHER
Imperial College London
OTHER
Engineering and Physical Sciences Research Council, UK
OTHER
University of Southampton
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Steven L Bell, Dr
Role: PRINCIPAL_INVESTIGATOR
University of Southampton
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal Berkshire NHS Foundation Trust
Reading, Berkshire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
30123
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.