Trial Outcomes & Findings for Role of the Auditory Efferent System in Auditory Perceptual Learning (NCT NCT02574247)

Last Updated: 2018-01-05

Results Overview

Decibel difference in medial olivocochlear reflex inhibition computed between final visit and baseline visit, where medial olivocochlear reflex inhibition is quantified as amplitude difference (in decibels) between transient-evoked otoacoustic emissions obtained with versus without broadband noise presented to the contralateral ear.

Recruitment status

TERMINATED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

First and last measurements (baseline and last session up to a year later)

Results posted on

2018-01-05

Participant Flow

Participants were randomly assigned to Training and Control groups a priori.

Participant milestones

Participant milestones
Measure	Training Participants in the Training arm will undergo 15 hours of computerized auditory training across 10 laboratory visits. Medial olivocochlear reflex function and speech perception abilities will be measured before, during, and after the training visits to examine the changes in the measurements across time. Computerized auditory training: 10 sessions of computerized auditory training (1.5 hr/session) for up to 1 year.	Control Participants in the Control arm will undergo the same number of visits as the Training arm, but will not participate in computerized auditory training. Medial olivocochlear reflex function and speech perception abilities will be measured at each visit to establish the test-retest reliability of these measurements in the absence of any training.	Speech Group Participants in the Speech Group will undergo 1 visit. Medial olivocochlear reflex function and speech perception abilities will be measured at this visit to establish the correlation between these measures in the absence of any training.
Overall Study STARTED	10	8	10
Overall Study COMPLETED	5	5	5
Overall Study NOT COMPLETED	5	3	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Training Participants in the Training arm will undergo 15 hours of computerized auditory training across 10 laboratory visits. Medial olivocochlear reflex function and speech perception abilities will be measured before, during, and after the training visits to examine the changes in the measurements across time. Computerized auditory training: 10 sessions of computerized auditory training (1.5 hr/session) for up to 1 year.	Control Participants in the Control arm will undergo the same number of visits as the Training arm, but will not participate in computerized auditory training. Medial olivocochlear reflex function and speech perception abilities will be measured at each visit to establish the test-retest reliability of these measurements in the absence of any training.	Speech Group Participants in the Speech Group will undergo 1 visit. Medial olivocochlear reflex function and speech perception abilities will be measured at this visit to establish the correlation between these measures in the absence of any training.
Overall Study Withdrawal by Subject	1	0	0
Overall Study Did not meet inclusion criteria	4	3	5

Baseline Characteristics

Results are reported for subjects meeting inclusion/exclusion criteria.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Training n=10 Participants Participants in the Training arm will undergo 15 hours of computerized auditory training across 10 laboratory visits. Medial olivocochlear reflex function and speech perception abilities will be measured before, during, and after the training visits to examine the changes in the measurements across time. Computerized auditory training: 10 sessions of computerized auditory training (1.5 hr/session) for up to 1 year.	Control n=8 Participants Participants in the Control arm will undergo the same number of visits as the Training arm, but will not participate in computerized auditory training. Medial olivocochlear reflex function and speech perception abilities will be measured at each visit to establish the test-retest reliability of these measurements in the absence of any training.	Speech Group n=10 Participants Participants in the Speech Group will undergo 1 visit. Medial olivocochlear reflex function and speech perception abilities will be measured at this visit to establish the correlation between these measures in the absence of any training.	Total n=28 Participants Total of all reporting groups
Age, Continuous	59.8 years STANDARD_DEVIATION 5.9 • n=10 Participants	63.0 years STANDARD_DEVIATION 5.2 • n=8 Participants	59.2 years STANDARD_DEVIATION 15.4 • n=10 Participants	61.6 years STANDARD_DEVIATION 9.4 • n=28 Participants
Sex: Female, Male Female	0 Participants n=10 Participants	3 Participants n=8 Participants	1 Participants n=10 Participants	4 Participants n=28 Participants
Sex: Female, Male Male	10 Participants n=10 Participants	5 Participants n=8 Participants	9 Participants n=10 Participants	24 Participants n=28 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=10 Participants	1 Participants n=8 Participants	2 Participants n=10 Participants	4 Participants n=28 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=10 Participants	7 Participants n=8 Participants	8 Participants n=10 Participants	24 Participants n=28 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants	0 Participants n=8 Participants	0 Participants n=10 Participants	0 Participants n=28 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=8 Participants	0 Participants n=10 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Asian	0 Participants n=10 Participants	1 Participants n=8 Participants	0 Participants n=10 Participants	1 Participants n=28 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=8 Participants	0 Participants n=10 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Black or African American	3 Participants n=10 Participants	2 Participants n=8 Participants	0 Participants n=10 Participants	5 Participants n=28 Participants
Race (NIH/OMB) White	6 Participants n=10 Participants	5 Participants n=8 Participants	8 Participants n=10 Participants	19 Participants n=28 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants	0 Participants n=8 Participants	2 Participants n=10 Participants	2 Participants n=28 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=10 Participants	0 Participants n=8 Participants	0 Participants n=10 Participants	1 Participants n=28 Participants
Region of Enrollment United States	10 participants n=10 Participants	8 participants n=8 Participants	10 participants n=10 Participants	28 participants n=28 Participants
Medial Olivocochlear Reflex Inhibition	1.4 decibels n=5 Participants • Results are reported for subjects meeting inclusion/exclusion criteria.	0.6 decibels n=5 Participants • Results are reported for subjects meeting inclusion/exclusion criteria.	1.9 decibels n=5 Participants • Results are reported for subjects meeting inclusion/exclusion criteria.	1.4 decibels n=15 Participants • Results are reported for subjects meeting inclusion/exclusion criteria.
Performance on Untrained Speech Perception Tasks CRM at -9 dB SNR	28 Percentage correct n=5 Participants • Results are displayed for participants meeting inclusion/exclusion criteria.	26 Percentage correct n=5 Participants • Results are displayed for participants meeting inclusion/exclusion criteria.	28 Percentage correct n=5 Participants • Results are displayed for participants meeting inclusion/exclusion criteria.	28 Percentage correct n=15 Participants • Results are displayed for participants meeting inclusion/exclusion criteria.
Performance on Untrained Speech Perception Tasks CRM at -6 dB SNR	62 Percentage correct n=5 Participants • Results are displayed for participants meeting inclusion/exclusion criteria.	58 Percentage correct n=5 Participants • Results are displayed for participants meeting inclusion/exclusion criteria.	62 Percentage correct n=5 Participants • Results are displayed for participants meeting inclusion/exclusion criteria.	62 Percentage correct n=15 Participants • Results are displayed for participants meeting inclusion/exclusion criteria.
Performance on Untrained Speech Perception Tasks IEEE at -6 dB SNR	14 Percentage correct n=5 Participants • Results are displayed for participants meeting inclusion/exclusion criteria.	21 Percentage correct n=5 Participants • Results are displayed for participants meeting inclusion/exclusion criteria.	17 Percentage correct n=5 Participants • Results are displayed for participants meeting inclusion/exclusion criteria.	17 Percentage correct n=15 Participants • Results are displayed for participants meeting inclusion/exclusion criteria.
Performance on Untrained Speech Perception Tasks IEEE at -3 dB SNR	62 Percentage correct n=5 Participants • Results are displayed for participants meeting inclusion/exclusion criteria.	56 Percentage correct n=5 Participants • Results are displayed for participants meeting inclusion/exclusion criteria.	47 Percentage correct n=5 Participants • Results are displayed for participants meeting inclusion/exclusion criteria.	56 Percentage correct n=15 Participants • Results are displayed for participants meeting inclusion/exclusion criteria.

PRIMARY outcome

Timeframe: First and last measurements (baseline and last session up to a year later)

Population: Due to the small sample size in each group, statistical comparisons between groups were not performed. Data were not collected in the Speech Group.

Outcome measures

Outcome measures
Measure	Training n=5 Participants Participants in the Training arm will undergo 15 hours of computerized auditory training across 10 laboratory visits. Medial olivocochlear reflex function and speech perception abilities will be measured before, during, and after the training visits to examine the changes in the measurements across time. Computerized auditory training: 10 sessions of computerized auditory training (1.5 hr/session) for up to 1 year.	Control n=5 Participants Participants in the Control arm will undergo the same number of visits as the Training arm, but will not participate in computerized auditory training. Medial olivocochlear reflex function and speech perception abilities will be measured at each visit to establish the test-retest reliability of these measurements in the absence of any training.	Speech Group Participants in the Speech Group will undergo 1 visit. Medial olivocochlear reflex function and speech perception abilities will be measured at this visit to establish the correlation between these measures in the absence of any training.
Change in Magnitude of Medial Olivocochlear Reflex Inhibition	-0.82 decibel difference Interval -3.71 to -0.08	-0.49 decibel difference Interval -1.23 to 0.49	—

PRIMARY outcome

Timeframe: Baseline (First study visit - 3 hour session)

Population: In order to increase statistical power, the baseline results for medial olivocochlear reflex inhibition results and speech perception from the Training, Control, and Speech Groups were pooled for this analysis

Spearman rank correlation computed between medial olivocochlear reflex inhibition (in decibels) and performance (in percent correct) on Coordinate Response Measure (CRM) task and Institute of Electrical and Electronics Engineers (IEEE) sentences, each presented at two decibel signal-to-noise ratios (dB SNR). Results obtained at first study visit.

Outcome measures

Outcome measures
Measure	Training n=15 Participants Participants in the Training arm will undergo 15 hours of computerized auditory training across 10 laboratory visits. Medial olivocochlear reflex function and speech perception abilities will be measured before, during, and after the training visits to examine the changes in the measurements across time. Computerized auditory training: 10 sessions of computerized auditory training (1.5 hr/session) for up to 1 year.	Control Participants in the Control arm will undergo the same number of visits as the Training arm, but will not participate in computerized auditory training. Medial olivocochlear reflex function and speech perception abilities will be measured at each visit to establish the test-retest reliability of these measurements in the absence of any training.	Speech Group Participants in the Speech Group will undergo 1 visit. Medial olivocochlear reflex function and speech perception abilities will be measured at this visit to establish the correlation between these measures in the absence of any training.
Association Between Medial Olivocochlear Reflex Inhibition and Untrained Speech Perception Tasks CRM at -9 dB SNR	-0.18 Spearman Rank Correlation Coefficient	—	—
Association Between Medial Olivocochlear Reflex Inhibition and Untrained Speech Perception Tasks CRM at -6 dB SNR	0.28 Spearman Rank Correlation Coefficient	—	—
Association Between Medial Olivocochlear Reflex Inhibition and Untrained Speech Perception Tasks IEEE at -6 dB SNR	-0.06 Spearman Rank Correlation Coefficient	—	—
Association Between Medial Olivocochlear Reflex Inhibition and Untrained Speech Perception Tasks IEEE at -3 dB SNR	0.45 Spearman Rank Correlation Coefficient	—	—

SECONDARY outcome

Timeframe: First and last measurements (baseline and last session up to a year later)

Population: Due to the small sample size, statistical analyses of group data were not performed. Data were not collected in the Control or Speech groups.

Difference in percent correct of auditory training sentences, computed between first and last measurements.

Outcome measures

Outcome measures
Measure	Training n=5 Participants Participants in the Training arm will undergo 15 hours of computerized auditory training across 10 laboratory visits. Medial olivocochlear reflex function and speech perception abilities will be measured before, during, and after the training visits to examine the changes in the measurements across time. Computerized auditory training: 10 sessions of computerized auditory training (1.5 hr/session) for up to 1 year.	Control Participants in the Control arm will undergo the same number of visits as the Training arm, but will not participate in computerized auditory training. Medial olivocochlear reflex function and speech perception abilities will be measured at each visit to establish the test-retest reliability of these measurements in the absence of any training.	Speech Group Participants in the Speech Group will undergo 1 visit. Medial olivocochlear reflex function and speech perception abilities will be measured at this visit to establish the correlation between these measures in the absence of any training.
Change in Auditory Training Sentence Task Performance	3 Difference in percentage correct Interval -2.0 to 12.0	—	—

SECONDARY outcome

Timeframe: First and last measurements (baseline and last session up to a year later)

Population: Due to the small sample size, statistical analyses of group data were not performed. Data were not collected in the Control or Speech groups.

Difference in signal-to-noise ratio (in decibels) on auditory training phoneme tasks (onsets, nuclei, and codas), computed between first and last measurement.

Outcome measures

Outcome measures
Measure	Training n=5 Participants Participants in the Training arm will undergo 15 hours of computerized auditory training across 10 laboratory visits. Medial olivocochlear reflex function and speech perception abilities will be measured before, during, and after the training visits to examine the changes in the measurements across time. Computerized auditory training: 10 sessions of computerized auditory training (1.5 hr/session) for up to 1 year.	Control Participants in the Control arm will undergo the same number of visits as the Training arm, but will not participate in computerized auditory training. Medial olivocochlear reflex function and speech perception abilities will be measured at each visit to establish the test-retest reliability of these measurements in the absence of any training.	Speech Group Participants in the Speech Group will undergo 1 visit. Medial olivocochlear reflex function and speech perception abilities will be measured at this visit to establish the correlation between these measures in the absence of any training.
Change in Auditory Training Phoneme Task Performance Onsets	-4.38 Signal-to-noise ratio change in decibels Interval -22.98 to -1.99	—	—
Change in Auditory Training Phoneme Task Performance Nuclei	-2.99 Signal-to-noise ratio change in decibels Interval -6.14 to 2.83	—	—
Change in Auditory Training Phoneme Task Performance Codas	-2.60 Signal-to-noise ratio change in decibels Interval -10.99 to 10.37	—	—

POST_HOC outcome

Timeframe: Baseline (First study visit - 3 hour session)

Partial Spearman rank correlation computed between medial olivocochlear reflex inhibition (in decibels) and slope of the psychometric function (in decibel per decibel) of untrained speech tasks (Coordinate Response Measure -- CRM; Institute of Electrical and Electronics Engineers -- IEEE) obtained from performance across two signal-to-noise ratios. Age and high-frequency pure-tone average were controlled for in this post-hoc analysis. Results obtained at first study visit.

Outcome measures

Outcome measures
Measure	Training n=15 Participants Participants in the Training arm will undergo 15 hours of computerized auditory training across 10 laboratory visits. Medial olivocochlear reflex function and speech perception abilities will be measured before, during, and after the training visits to examine the changes in the measurements across time. Computerized auditory training: 10 sessions of computerized auditory training (1.5 hr/session) for up to 1 year.	Control Participants in the Control arm will undergo the same number of visits as the Training arm, but will not participate in computerized auditory training. Medial olivocochlear reflex function and speech perception abilities will be measured at each visit to establish the test-retest reliability of these measurements in the absence of any training.	Speech Group Participants in the Speech Group will undergo 1 visit. Medial olivocochlear reflex function and speech perception abilities will be measured at this visit to establish the correlation between these measures in the absence of any training.
Association Between Medial Olivocochlear Reflex Inhibition and Slope of the Psychometric Function of Untrained Speech Perception Tasks CRM Slope	0.59 Spearman partial rank correlation	—	—
Association Between Medial Olivocochlear Reflex Inhibition and Slope of the Psychometric Function of Untrained Speech Perception Tasks IEEE Slope	0.60 Spearman partial rank correlation	—	—

Adverse Events

Training

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Speech Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Training n=10 participants at risk Participants in the Training arm will undergo 15 hours of computerized auditory training across 10 laboratory visits. Medial olivocochlear reflex function and speech perception abilities will be measured before, during, and after the training visits to examine the changes in the measurements across time. Computerized auditory training: 10 sessions of computerized auditory training (1.5 hr/session) for up to 1 year.	Control n=8 participants at risk Participants in the Control arm will undergo the same number of visits as the Training arm, but will not participate in computerized auditory training. Medial olivocochlear reflex function and speech perception abilities will be measured at each visit to establish the test-retest reliability of these measurements in the absence of any training.	Speech Group n=10 participants at risk Participants in the Speech Group will undergo 1 visit. Medial olivocochlear reflex function and speech perception abilities will be measured at this visit to establish the correlation between these measures in the absence of any training.
Gastrointestinal disorders Gastrointestinal pain	10.0% 1/10 • Number of events 1 • Through study completion, maximum of 1 year. Definition of adverse event and/or serious adverse event are consistent with clincialtrials.gov definitions.	0.00% 0/8 • Through study completion, maximum of 1 year. Definition of adverse event and/or serious adverse event are consistent with clincialtrials.gov definitions.	0.00% 0/10 • Through study completion, maximum of 1 year. Definition of adverse event and/or serious adverse event are consistent with clincialtrials.gov definitions.

Additional Information

Dr. Ian Mertes

University of Illinois at Urbana-Champaign

Phone: 217-300-4756

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place