Trial Outcomes & Findings for Stream Segregation and Speech Recognition in Noise in Individuals With Cochlear Implants (NCT NCT04854031)

NCT ID: NCT04854031

Last Updated: 2023-05-18

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 8 participants
• Primary outcome timeframe: Up to 30 minutes in each of two listening conditions.
• Results posted on: 2023-05-18

Participant Flow

Participant milestones

Measure	Cochlear Implant Recipients 8 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. 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.
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Cochlear Implant Recipients n=8 Participants 8 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. 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 30 minutes in each of two listening conditions.

Population: The entire population

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.

Outcome measures

Measure	Cochlear Implant Recipients n=8 Participants 8 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. 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.
Speech Recognition In quiet	62 percentage of keywords correct Interval 30.0 to 80.0
Speech Recognition In +10 decibel target-to-masker ratio two-talker babble	22 percentage of keywords correct Interval 9.0 to 28.0

PRIMARY outcome

Timeframe: Up to 30 minutes

Population: The entire population

The metric for temporal modulation detection is the modulation depth relative to 100% modulation which the participant can detect 71% of the time.

Outcome measures

Measure

Cochlear Implant Recipients n=8 Participants 8 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. 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.

Temporal Modulation Detection Threshold

-3.1 decibels relative to 100% modulation Interval -6.2 to -0.4

PRIMARY outcome

Timeframe: Up to 30 minutes

Population: The entire population

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.

Outcome measures

Measure

Cochlear Implant Recipients n=8 Participants 8 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. 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.

Spectral Modulation Detection Thresholds

12.8 decibels peak-to-valley ratio Interval 4.8 to 34.0

PRIMARY outcome

Timeframe: Up to 20 minutes

Population: The entire population

The outcome is the percentage of letters recalled in the correct position across all trials, out of a total of 75 letters.

Outcome measures

Measure

Cochlear Implant Recipients n=8 Participants 8 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. 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.

Reading Span Task Performance

57 Percentage of Letters Recalled Interval 33.0 to 91.0

PRIMARY outcome

Timeframe: Up to 20 minutes

Population: The entire population

The outcome is the total percentage of digits recalled in the correct position across all trials, out of a maximum of 220.

Outcome measures

Measure

Cochlear Implant Recipients n=8 Participants 8 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. 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.

Digit Span Task Performance

64 percentage of digits recalled Interval 49.0 to 92.0

PRIMARY outcome

Timeframe: Up to 10 minutes

Population: The entire population

The outcome is the average number of words recalled from each list, with a possible maximum of 12.

Outcome measures

Measure

Cochlear Implant Recipients n=8 Participants 8 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. 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.

Free Recall Task Performance

3.3 average number of words recalled Interval 2.1 to 4.8

PRIMARY outcome

Timeframe: Up to 20 minutes

Population: The entire population

The outcome is the percentage of numbers correctly recalled across boxes, out of a total of 49.

Outcome measures

Measure

Cochlear Implant Recipients n=8 Participants 8 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. 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.

Digit Updating Task Performance

57 Percentage of numbers recalled Interval 18.0 to 86.0

PRIMARY outcome

Timeframe: Up to 15 minutes

Population: The entire population

The outcome is the average number of digits recalled in the correct position relative to the last item in the sequence across lists.

Outcome measures

Measure

Cochlear Implant Recipients n=8 Participants 8 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. 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.

Running Digit Span Task Performance

2.4 Average number of digits recalled Interval 1.1 to 3.9

PRIMARY outcome

Timeframe: Up to 1 hour

Population: The entire population

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).

Outcome measures

Measure	Cochlear Implant Recipients n=8 Participants 8 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. 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.
Stream Segregation 85 Hz Target, 200 Hz Distractor	12.5 Percentage difference in digits recalled Interval -20.0 to 43.0
Stream Segregation 120 Hz Target, 200 Hz Distractor	12.5 Percentage difference in digits recalled Interval -35.0 to 43.0
Stream Segregation 150 Hz Target, 200 Hz Distractor	16 Percentage difference in digits recalled Interval -8.0 to 42.0

Adverse Events

Cochlear Implant Recipients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Adam Bosen

Boys Town National Research Hospital

Phone: 531-355-5030

Email: adam.bosen@boystown.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place