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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Boys Town National Research Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Cochlear Implants
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 30 minutes in each of two listening conditions.
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.
Up to 30 minutes
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.
Up to 30 minutes
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.
Up to 20 minutes
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.
Up to 20 minutes
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.
Up to 10 minutes
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.
Up to 20 minutes
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.
Up to 15 minutes
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).
Up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Father Flanagan's Boys' Home

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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