- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04854031
Stream Segregation and Speech Recognition in Noise in Individuals With Cochlear Implants
April 24, 2023 updated by: Adam Bosen, Father Flanagan's Boys' Home
Individuals with cochlear implants will complete tasks which measure auditory resolution, working memory, stream segregation, and speech recognition in the presence of competing speech using their everyday clinical device settings.
The relationship between these tasks will be examined to identify the factors which predict successful speech recognition in the presence of competing speech.
Study Overview
Detailed Description
Individuals with cochlear implants struggle to understand speech in the presence of competing talkers because they have trouble segregating auditory streams.
The premise of this project is that individual differences in auditory resolution and cognitive ability across individuals with cochlear implants determine the extent to which they can segregate auditory streams from one another and hear out target speech embedded in competing talkers.
Our goal is to test whether the link between speech recognition in noise and individual differences in auditory resolution and working memory in individuals with cochlear implants is due to the limitations that these individual differences place on stream segregation.
The outcome measure to be predicted is sentence recognition in two-talker babble.
Previous work has found that spectral and temporal modulation detection thresholds (measures of auditory resolution) and performance on the reading span task (a measure of working memory that is closely linked to fluid intelligence) are predictors of speech recognition in quiet.
To account for these sources of variability in speech recognition, we will verify that these tasks jointly predict individual differences in sentence recognition in quiet.
Adding competing talkers during the speech recognition task will introduce additional variability beyond the variability of speech recognition in quiet.
We hypothesize that this additional variability with competing talkers should be predicted by individual differences in stream segregation ability, which will in turn be predicted by auditory resolution and working memory.
Obligatory and voluntary stream segregation ability will be measured using rapidly presented digit sequences manipulated to have alternating fundamental frequencies (F0) for each digit.
Participants will resist integration and repeat back only the digits presented with the higher F0.
The magnitude of the F0 alternation will be manipulated to control the difficulty of segregating streams.
The predicted relationship between stream segregation and sentence recognition will be tested for auditory resolution and working memory in independent and combined models.
Completing this goal will identify the auditory and cognitive factors that support stream segregation in post-lingually deafened adults with cochlear implants.
This identification will enable development of cochlear implant design and rehabilitation strategies to facilitate stream segregation in these patients as well as investigation of the developmental trajectories of these factors in children with cochlear implants.
We plan to implement this study in at-home testing conditions to avoid risking coronavirus disease 2019 transmission in the lab, so this work will also determine the feasibility of at-home testing of individuals with cochlear implants.
At-home testing would expand the amount and diversity of participants we are able to recruit for future studies.
Study Type
Observational
Enrollment (Actual)
8
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nebraska
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Omaha, Nebraska, United States, 68131
- Boys Town National Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Individuals with Cochlear Implants who are enrolled in the Boys Town National Research Hospital research database
Description
Inclusion Criteria:
- Has at least one cochlear implant.
- Lost their hearing during adulthood.
- Native English speaker.
Exclusion Criteria:
- Cognitive impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cochlear Implant Recipients
30 participants who lost their hearing and received one or two cochlear implants as adults will participate in this study.
We will include unilaterally and bilaterally implanted individuals listening with their everyday hearing configuration.
Individuals with residual acoustic hearing better than 60 A-weighted decibels at any audiometric frequency will be excluded.
Participants will range in age between 19 and 80 years old, although most are expected to be within 50 - 75 years of age.
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Individuals with cochlear implants will be tested on their hearing ability.
Auditory recordings of speech will be played to participants from a loudspeaker.
Recordings will be edited to add competing noise sources and to adjust talker voice pitch.
Synthetic sounds will be manipulated to control auditory cue salience in detection tasks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speech Recognition
Time Frame: Up to 30 minutes in each of two listening conditions.
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The metric for speech recognition is the percentage of Perceptually Robust English Sentence Test Open-set (PRESTO) sentence keywords that were correctly repeated in order.
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Up to 30 minutes in each of two listening conditions.
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Temporal Modulation Detection Threshold
Time Frame: Up to 30 minutes
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The metric for temporal modulation detection is the modulation depth relative to 100% modulation which the participant can detect 71% of the time.
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Up to 30 minutes
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Spectral Modulation Detection Thresholds
Time Frame: Up to 30 minutes
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The metric for spectral modulation detection is the magnitude of the peak-to-valley ratio of the spectrally modulated stimulus which the participant can detect 71% of the time.
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Up to 30 minutes
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Reading Span Task Performance
Time Frame: Up to 20 minutes
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The outcome is the percentage of letters recalled in the correct position across all trials, out of a total of 75 letters.
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Up to 20 minutes
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Digit Span Task Performance
Time Frame: Up to 20 minutes
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The outcome is the total percentage of digits recalled in the correct position across all trials, out of a maximum of 220.
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Up to 20 minutes
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Free Recall Task Performance
Time Frame: Up to 10 minutes
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The outcome is the average number of words recalled from each list, with a possible maximum of 12.
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Up to 10 minutes
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Digit Updating Task Performance
Time Frame: Up to 20 minutes
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The outcome is the percentage of numbers correctly recalled across boxes, out of a total of 49.
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Up to 20 minutes
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Running Digit Span Task Performance
Time Frame: Up to 15 minutes
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The outcome is the average number of digits recalled in the correct position relative to the last item in the sequence across lists.
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Up to 15 minutes
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Stream Segregation
Time Frame: Up to 1 hour
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The metric for stream segregation is the percent change in digit recall that occurs when voice pitch differs from the distractor digits (85, 120, and 150 Hz) relative to when voice pitch between target and distractor digits is the same (200 Hz).
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Up to 1 hour
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adam K Bosen, Father Flanagan's Boys' Home
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 2, 2021
Primary Completion (Actual)
March 31, 2022
Study Completion (Actual)
March 31, 2022
Study Registration Dates
First Submitted
April 16, 2021
First Submitted That Met QC Criteria
April 19, 2021
First Posted (Actual)
April 22, 2021
Study Record Updates
Last Update Posted (Actual)
May 18, 2023
Last Update Submitted That Met QC Criteria
April 24, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 5P20GM109023-07 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified results from all experimental tasks will be made publicly available through the Open Science Framework.
Relevant demographic information will be provided for each participant.
IPD Sharing Time Frame
Following completion of the study and publication of results in a peer-reviewed journal.
IPD Sharing Access Criteria
Publicly available
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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