Stream Segregation and Speech Recognition in Noise in Individuals With Cochlear Implants

• ClinicalTrials.gov Identifier: NCT04854031
• Recruitment Status: Recruiting
• First Posted: April 22, 2021
• Last Update Posted: March 8, 2022
• Sponsor: Father Flanagan's Boys' Home
• Information provided by (Responsible Party): Adam Bosen, Father Flanagan's Boys' Home

Study Description

Brief 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. The relationship between these tasks will be examined to identify the factors which predict successful speech recognition in the presence of competing speech.

Condition or disease	Intervention/treatment
Cochlear Implants	Device: Cochlear Implants

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 COVID 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

• Study Type: Observational
• Estimated Enrollment: 30 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Stream Segregation and Speech Recognition in Noise in Individuals With Cochlear Implants
• Actual Study Start Date: August 2, 2021
• Estimated Primary Completion Date: October 31, 2022
• Estimated Study Completion Date: October 31, 2022

Groups and Cohorts

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 dBA 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.

Outcome Measures

Primary Outcome Measures :

1. Speech Recognition [ Time Frame: Up to 1 hour ]
   The metric for speech recognition will be the proportion of target sentence keywords correctly repeated in order
2. Working Memory [ Time Frame: Up to 2 hours ]
   The metrics for working memory will be the total number of memoranda recalled in each task
3. Auditory cue detection [ Time Frame: Up to 1 hour ]
   The metric for auditory cue detection will be the magnitude of the cue which the participant can detect 71% of the time.
4. Stream Segregation [ Time Frame: Up to 1 hour ]
   The metric for stream segregation will be the change in target digit recall that occurs with differences in voice pitch between target and distractor digits.

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Criteria

Inclusion Criteria:

• Has at least one cochlear implant.
• Lost their hearing during adulthood.
• Native English speaker.

Exclusion Criteria:

• Cognitive impairment

Contacts and Locations

Contacts

Contact: Adam K Bosen; 5313555030; adam.bosen@boystown.org

Locations

United States, Nebraska

Boys Town National Research Hospital; Recruiting

Omaha, Nebraska, United States, 68131

Contact: Adam K Bosen, Ph.D. 531-355-5030 adam.bosen@boystown.org

Contact: Adity

Sponsors and Collaborators

Father Flanagan's Boys' Home

Investigators

• Principal Investigator: Adam K Bosen; Father Flanagan's Boys' Home

More Information

• Responsible Party: Adam Bosen, Director, Auditory Perceptual Encoding Laboratory, Father Flanagan's Boys' Home
• ClinicalTrials.gov Identifier: NCT04854031
• Other Study ID Numbers: 5P20GM109023-07 ( U.S. NIH Grant/Contract )
• First Posted: April 22, 2021
• Last Update Posted: March 8, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code
• Time Frame: Following completion of the study and publication of results in a peer-reviewed journal.
• Access Criteria: Publicly available

• 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