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

NCT04854031 | Completed Results FDA Device

• 1 other identifier: 5P20GM109023-07
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Cochlear Implants

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  Up to 1 hour

Study Arms (1)

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

Interventions

Cochlear Implants DEVICE

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.

Cochlear Implant Recipients

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with Cochlear Implants who are enrolled in the Boys Town National Research Hospital research database

You may qualify if:

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

You may not qualify if:

• Cognitive impairment

Sponsors & Collaborators

• Father Flanagan's Boys' Home: lead

Study Sites (1)

Boys Town National Research Hospital

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Interventions

Cochlear Implants

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Limitations and Caveats

Recruiting difficulties lead to a smaller total number of participants than planned.

Results Point of Contact

• Title: Adam Bosen
• Organization: Boys Town National Research Hospital

adam.bosen@boystown.org

531-355-5030

Study Officials

• Adam K Bosen

  Father Flanagan's Boys' Home

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Auditory Perceptual Encoding Laboratory

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 22, 2021
• Study Start: August 2, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: May 18, 2023
• Results First Posted: May 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Following completion of the study and publication of results in a peer-reviewed journal.
• Access Criteria: Publicly available

Locations

US (1)