Cochlear ImplantsNCT04854031
Stream Segregation and Speech Recognition in Noise in Individuals With Cochlear Implants
An observational study of Cochlear Implants, run by Father Flanagan's Boys' Home at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Cochlear Implants
- What is being tested?
- Cochlear Implants
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2021to 31 Mar 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with Cochlear Implants who are enrolled in the Boys Town National Research Hospital research database
Who may be able to join
- Has at least one cochlear implant.
- Lost their hearing during adulthood.
- Native English speaker.
Who cannot join
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Boys Town National Research Hospital
Omaha, Nebraska, 68131
About this study
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.
Read the 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.
- Conditions
- Cochlear Implants
- Being tested
- Cochlear Implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear ImplantsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cochlear Implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Recognition
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.
Measured: Up to 30 minutes in each of two listening conditions.
Temporal Modulation Detection Threshold
The metric for temporal modulation detection is the modulation depth relative to 100% modulation which the participant can detect 71% of the time.
Measured: Up to 30 minutes
Spectral Modulation Detection Thresholds
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.
Measured: Up to 30 minutes
Reading Span Task Performance
The outcome is the percentage of letters recalled in the correct position across all trials, out of a total of 75 letters.
Measured: Up to 20 minutes
Digit Span Task Performance
The outcome is the total percentage of digits recalled in the correct position across all trials, out of a maximum of 220.
Measured: Up to 20 minutes
Free Recall Task Performance
The outcome is the average number of words recalled from each list, with a possible maximum of 12.
Measured: Up to 10 minutes
Digit Updating Task Performance
The outcome is the percentage of numbers correctly recalled across boxes, out of a total of 49.
Measured: Up to 20 minutes
Running Digit Span Task Performance
The outcome is the average number of digits recalled in the correct position relative to the last item in the sequence across lists.
Measured: Up to 15 minutes
Stream Segregation
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).
Measured: Up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start2 Aug 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cochlear ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Father Flanagan's Boys' Home
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Bosen, Father Flanagan's Boys' Home
- Investigators
- Adam K Bosen, Principal investigator, Father Flanagan's Boys' Home
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854031
- Sponsor's protocol ID
- 5P20GM109023-07
- Status last verified
- Apr 2023
- First submitted
- 16 Apr 2021
- Last updated
- 18 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stream Segregation and Speech Recognition in Noise in Individuals With Cochlear Implants
- ClinicalTrials.gov ID
- NCT04854031
- Acronym / sponsor ID
- 5P20GM109023-07
- Conditions
- Cochlear Implants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Father Flanagan's Boys' HomeUniversity, hospital or other
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Posted 18 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear Implant Recipients | – | Device: Cochlear Implants30 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. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with Cochlear Implants who are enrolled in the Boys Town National Research Hospital research database
Key inclusion criteria (3 listed)
- Has at least one cochlear implant.
- Lost their hearing during adulthood.
- Native English speaker.
Key exclusion criteria (1 listed)
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear ImplantsIndividuals 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. | Device | Cochlear Implant Recipients |
Primary outcome
Speech Recognition
Time frame: Up to 30 minutes in each of two listening conditions.
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.
Temporal Modulation Detection Threshold
Time frame: Up to 30 minutes
The metric for temporal modulation detection is the modulation depth relative to 100% modulation which the participant can detect 71% of the time.
Spectral Modulation Detection Thresholds
Time frame: Up to 30 minutes
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.
Reading Span Task Performance
Time frame: Up to 20 minutes
The outcome is the percentage of letters recalled in the correct position across all trials, out of a total of 75 letters.
Digit Span Task Performance
Time frame: Up to 20 minutes
The outcome is the total percentage of digits recalled in the correct position across all trials, out of a maximum of 220.
Free Recall Task Performance
Time frame: Up to 10 minutes
The outcome is the average number of words recalled from each list, with a possible maximum of 12.
Digit Updating Task Performance
Time frame: Up to 20 minutes
The outcome is the percentage of numbers correctly recalled across boxes, out of a total of 49.
Running Digit Span Task Performance
Time frame: Up to 15 minutes
The outcome is the average number of digits recalled in the correct position relative to the last item in the sequence across lists.
Stream Segregation
Time frame: Up to 1 hour
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam K Bosen principal investigator
Father Flanagan's Boys' Home
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cochlear Implants, run by Father Flanagan's Boys' Home at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech Recognition (time frame: Up to 30 minutes in each of two listening conditions.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.