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Role of the Auditory Efferent System in Auditory Perceptual Learning

Role of the Auditory Efferent System in Auditory Perceptual Learning

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02574247
Enrollment
28
Registered
2015-10-12
Start date
2016-03-29
Completion date
2017-05-17
Last updated
2018-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Auditory Training and Auditory Efferent System

Keywords

Audiology, Auditory Pathways, Auditory Perception, Brain Stem, Cochlea, Ear, Inner, Efferent Pathways, Hair Cells, Auditory, Outer, Learning, Neurons, Efferent, Speech Perception

Brief summary

The purpose of this study is to determine how changes in speech perception resulting from a computerized auditory training program are related to concurrent changes in auditory brainstem function resulting from the training. It is hypothesized that the degree of improvement in speech perception will be correlated with the degree of change in brainstem function.

Detailed description

The goal of this study is to determine the impact of an auditory training program on the function of the inner ear and auditory brainstem. In normal-hearing individuals, the medial olivocochlear (MOC) branch of the auditory efferent system appears to aid with hearing signals in noise. A previous study in young normal-hearing adults found that auditory training strengthened the function of the MOC system in some participants in a way that coincided with their improvements in perceiving speech sounds in background noise. The MOC function measured at baseline also predicted the amount of success from the auditory training. Although these results are promising, it is not known if they generalize to populations that often have hearing-in-noise problems such as older and hearing-impaired adults. This study will examine how an auditory training program impacts MOC activity in a group of older adults with normal hearing or mild hearing loss. This is a prospective study utilizing a repeated-measures design. Participants will participate in a computerized auditory training program taking place over 15 weeks. Transient-evoked otoacoustic emissions (TEOAEs) will be used to measure the strength of MOC activity at each visit. Performance on untrained stimuli (words and sentences) will also be measured. A control group (no auditory training) will also be used to establish test-retest reliability for TEOAE measurements and performance on the word and sentence testing. The results of this study may contribute to the improved diagnosis and treatment of hearing-in-noise problems in Veterans and in the civilian population. This is a single-site study that will take place at the Auditory Research Laboratory, located at the VA Loma Linda Healthcare System (VALLHS) in Loma Linda, California. Veterans and non-Veterans, both males and females, between the ages of 35 and 89 with either normal hearing or mild sensorineural hearing loss will participate. Women and minorities will be encouraged to participate. Up to 200 volunteers will be enrolled in the study. Each eligible participant will participate in a maximum of 14 study visits. Participants will be randomly assigned a priori to either the experimental group (auditory training) or Control group (no auditory training) using simple random assignment. Because this study will detect whether or not significant changes in MOC activity and speech perception across time occurred as a result of auditory training, the Control group is needed to establish the test-retest reliability of our outcome measures in the absence of any training. Preliminary analyses of the data showed an association between a measure of speech perception and the strength of the efferent system. To increase statistical power in examination of this association, an additional group (Speech Group) is incorporated that includes subjects that only participate in one session, with only the measurements of speech recognition and medial olivocochlear reflex activity. The Speech Group will be assigned by the investigators. This study consists of one experiment that will last 3 years total. Each participant in the Experimental and Control groups will participate in 12 study visits, ideally over a 15-week period. However, we will allow for the visits to take place across a 1-year period to account for participants needing to miss or reschedule some visits. We will also allow 2 additional make-up visits for each participant (for a total of 14 visits), should they need to end an experimental session early. All study visits will last between 2-3 hours. Thus, the maximum amount of participation for each participant is 52 hours (14 visits x 3 hours per visit) across a 1-year period. Standard-of-care screenings and experimental testing will be carried out in a double-walled sound-isolated audiometric chamber adjoined to a single-walled room in the Auditory Research Laboratory, located at the VALLHS. Initial audiometric testing using standard-of-care procedures will be conducted to verify eligibility for the study and will be carried out using standard clinical equipment. Experimental tests will consist of Transient Evoked Otoacoustic Emissions (TEOAE) testing, word/sentence recognition testing, and an auditory training program (only participants in the Experimental group will undergo the auditory training). For TEOAE testing, the basic task of the participants is similar to TEOAE procedures used clinically to evaluate hearing function objectively. Testing involves listening to sounds presented through earphones while seated comfortably in a sound-treated booth, and remaining alert but quiet in order to successfully measure responses from the cochlea and brainstem. All stimuli will be presented at moderate volumes that are well below sound levels considered hazardous by Occupational Safety and Health Adminstration (OSHA) and NIOSH standards. TEOAE measurements consist of waveforms, which are changes in sound amplitude across time. Word/sentence testing involves listening to words and sentences presented through earphones while seated in the sound-treated booth. Speech stimuli will be presented in the presence of background noise. Participants make a response about the word(s) they heard. Sounds will be presented at safe and comfortable levels. For the auditory training program, listeners will be seated comfortably in the sound booth at a workstation with a computer screen, keyboard, and mouse. Sounds will be presented to the participants through insert earphones. Participants will make their responses concerning what they heard by mouse click or keyboard entry. The auditory training program consists of a curriculum of word and sentence presentations in various noise levels, and performance on repeated measurements are tracked throughout the subject's participation in the program. This is a minimal risk study. The participants will all be healthy adults (other than mild hearing loss in some participants). There are no foreseeable risks involved in these studies beyond those associated with routine audiological practice, such as boredom or fatigue during testing. All sound levels to be used in the study fall below the Damage Risk Criteria established by OSHA for intensity-duration interaction. Participants will be provided with as many breaks during testing as they or the experimenter feel are helpful to minimize mental fatigue and boredom. Loudness levels of stimuli are carefully controlled, with frequent calibration and monitoring of laboratory equipment. Participant confidentially will be protected by using only participant codes (three numbers) to label data collection sheets and computer data files. All data records will be stored on password-protected computers or as hard copy in locked offices or laboratories. Participant safety and comfort and data collection will be constantly monitored for each participant by the research team member collecting the data for that participant. Overall data collection will be monitored by the Principal Investigator. Following completion of the study, all data will be maintained in accordance with Veterans Health Administration guidelines. Regarding potential benefits of participating, all participants will receive an up-to-date hearing screening and a further understanding of their own hearing. Participants in the Experimental group may or may not notice an improved ability to hear sounds in background noise after undergoing auditory training. The knowledge gained from this study may also benefit individuals with hearing-in-noise problems by contributing to improved diagnosis and treatment of hearing-in-noise problems in Veterans and in the civilian population.

Interventions

PROCEDUREComputerized auditory training

10 sessions of computerized auditory training (1.5 hr/session) across a 15-week span.

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH
VA Loma Linda Health Care System
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 89 Years
Healthy volunteers
Yes

Inclusion criteria

* 3-frequency pure-tone average ≤40 decibels hearing level (dB HL) * Air-bone gaps ≤10 decibels (dB) from 500-4000 Hz * 226-Hz tympanograms within normal limits * Measurable acoustic reflexes bilaterally * Measurable transient-evoked otoacoustic emissions * Ability to read and speak English * Ability to comply with all test procedures * Ability to commute to VA Loma Linda Healthcare System 12 times

Exclusion criteria

* Hearing asymmetry \>15 decibels at three or more audiometric frequencies * Conductive hearing loss or otologic pathology * History of middle ear surgery * Chronic disease and/or use of medication that affects ability to participate in test procedures during study period

Design outcomes

Primary

MeasureTime frameDescription
Change in Magnitude of Medial Olivocochlear Reflex InhibitionFirst and last measurements (baseline and last session up to a year later)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.
Association Between Medial Olivocochlear Reflex Inhibition and Untrained Speech Perception TasksBaseline (First study visit - 3 hour session)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.

Secondary

MeasureTime frameDescription
Change in Auditory Training Sentence Task PerformanceFirst and last measurements (baseline and last session up to a year later)Difference in percent correct of auditory training sentences, computed between first and last measurements.
Change in Auditory Training Phoneme Task PerformanceFirst and last measurements (baseline and last session up to a year later)Difference in signal-to-noise ratio (in decibels) on auditory training phoneme tasks (onsets, nuclei, and codas), computed between first and last measurement.

Countries

United States

Participant flow

Pre-assignment details

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

Participants by arm

ArmCount
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.
10
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.
8
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.
10
Total28

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyDid not meet inclusion criteria435
Overall StudyWithdrawal by Subject100

Baseline characteristics

CharacteristicTrainingTotalSpeech GroupControl
Age, Continuous59.8 years
STANDARD_DEVIATION 5.9
61.6 years
STANDARD_DEVIATION 9.4
59.2 years
STANDARD_DEVIATION 15.4
63.0 years
STANDARD_DEVIATION 5.2
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants4 Participants2 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants24 Participants8 Participants7 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Medial Olivocochlear Reflex Inhibition1.4 decibels1.4 decibels1.9 decibels0.6 decibels
Performance on Untrained Speech Perception Tasks
CRM at -6 dB SNR
62 Percentage correct62 Percentage correct62 Percentage correct58 Percentage correct
Performance on Untrained Speech Perception Tasks
CRM at -9 dB SNR
28 Percentage correct28 Percentage correct28 Percentage correct26 Percentage correct
Performance on Untrained Speech Perception Tasks
IEEE at -3 dB SNR
62 Percentage correct56 Percentage correct47 Percentage correct56 Percentage correct
Performance on Untrained Speech Perception Tasks
IEEE at -6 dB SNR
14 Percentage correct17 Percentage correct17 Percentage correct21 Percentage correct
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
3 Participants5 Participants0 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants2 Participants2 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
White
6 Participants19 Participants8 Participants5 Participants
Region of Enrollment
United States
10 participants28 participants10 participants8 participants
Sex: Female, Male
Female
0 Participants4 Participants1 Participants3 Participants
Sex: Female, Male
Male
10 Participants24 Participants9 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 80 / 10
other
Total, other adverse events
1 / 100 / 80 / 10
serious
Total, serious adverse events
0 / 100 / 80 / 10

Outcome results

Primary

Association Between Medial Olivocochlear Reflex Inhibition and Untrained Speech Perception Tasks

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.

Time frame: 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

ArmMeasureGroupValue (NUMBER)
TrainingAssociation Between Medial Olivocochlear Reflex Inhibition and Untrained Speech Perception TasksCRM at -9 dB SNR-0.18 Spearman Rank Correlation Coefficient
TrainingAssociation Between Medial Olivocochlear Reflex Inhibition and Untrained Speech Perception TasksCRM at -6 dB SNR0.28 Spearman Rank Correlation Coefficient
TrainingAssociation Between Medial Olivocochlear Reflex Inhibition and Untrained Speech Perception TasksIEEE at -6 dB SNR-0.06 Spearman Rank Correlation Coefficient
TrainingAssociation Between Medial Olivocochlear Reflex Inhibition and Untrained Speech Perception TasksIEEE at -3 dB SNR0.45 Spearman Rank Correlation Coefficient
Comparison: Statistical analysis for the row CRM at -9 dB SNRp-value: 0.34Spearman partial rank correlation
Comparison: Statistical analysis for the row CRM at -6 dB SNRp-value: 0.64Spearman partial rank correlation
Comparison: Statistical analysis for the row IEEE at -6 dB SNRp-value: 0.24Spearman partial rank correlation
Comparison: Statistical analysis for the row IEEE at -3 dB SNRp-value: 0.2Spearman partial rank correlation
Primary

Change in Magnitude of Medial Olivocochlear Reflex Inhibition

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.

Time frame: 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.

ArmMeasureValue (MEDIAN)
TrainingChange in Magnitude of Medial Olivocochlear Reflex Inhibition-0.82 decibel difference
ControlChange in Magnitude of Medial Olivocochlear Reflex Inhibition-0.49 decibel difference
Secondary

Change in Auditory Training Phoneme Task Performance

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

Time frame: 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.

ArmMeasureGroupValue (MEDIAN)
TrainingChange in Auditory Training Phoneme Task PerformanceOnsets-4.38 Signal-to-noise ratio change in decibels
TrainingChange in Auditory Training Phoneme Task PerformanceNuclei-2.99 Signal-to-noise ratio change in decibels
TrainingChange in Auditory Training Phoneme Task PerformanceCodas-2.60 Signal-to-noise ratio change in decibels
Secondary

Change in Auditory Training Sentence Task Performance

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

Time frame: 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.

ArmMeasureValue (MEDIAN)
TrainingChange in Auditory Training Sentence Task Performance3 Difference in percentage correct
Post Hoc

Association Between Medial Olivocochlear Reflex Inhibition and Slope of the Psychometric Function of Untrained Speech Perception Tasks

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.

Time frame: 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.

ArmMeasureGroupValue (NUMBER)
TrainingAssociation Between Medial Olivocochlear Reflex Inhibition and Slope of the Psychometric Function of Untrained Speech Perception TasksCRM Slope0.59 Spearman partial rank correlation
TrainingAssociation Between Medial Olivocochlear Reflex Inhibition and Slope of the Psychometric Function of Untrained Speech Perception TasksIEEE Slope0.60 Spearman partial rank correlation
Comparison: Statistical analysis for the row CRM slopep-value: 0.03Spearman partial rank correlation
Comparison: Statistical analysis for row IEEE slopep-value: 0.04Spearman partial rank correlation

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026