Speech IntelligibilityNCT04997577
Speech Perception and High Cognitive Demand
A study testing Auditory-cognitive training paradigm and Auditory training paradigm in people with Speech Intelligibility and Aging, run by University of Maryland, College Park at 2 sites in United States.
Trial summary
With advancing age, adults experience increasing speech understanding difficulties in challenging situations. Currently, speech-in-noise difficulties are rehabilitated by providing hearing aids. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Speech Intelligibility, Aging
- What is being tested?
- Auditory-cognitive training paradigm and Auditory training paradigm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Sep 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged between 65 - 85 years
- Normal hearing (pure tone thresholds ≤ 25 dB HL from 250 - 8000 Hz)
- Self-reported normal or corrected-to-normal vision
- Dominant language: American English
- Education: a high school diploma or higher education level
Who cannot join
- Middle-ear or inner-ear pathology
- Non-native speaker of English
- Inability to complete all training sessions within a pre-specified time window (e.g., due to unexpected schedule restrictions)
- Learning disorders
- Metal in body that induces a data artifact for MEG recording (e.g., excessive metal dental work) or that poses a safety issue in the MRI portion (e.g., pacemakers, neural implants, metal plates or joints, shrapnel, and surgical staples)
- Claustrophobia or any condition that would be exacerbated by the scanning environment's lighting, sounds, etc. (e.g., migraines)
Show all 10Show fewer
- A non-removable hairstyle or hair accessory that would prevent the participant from fitting comfortably in the MEG or MRI head coil
- Currently under a medical provider's care for a closed head injury
- Currently taking psychoactive stimulant (e.g., amphetamines), depressant (e.g., benzodiazepines), mood stabilizing (e.g., lithium), anti-psychotic, or anti-seizure medications or drugs of abuse
- Currently pregnant (only for MRI)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Department of Hearing and Speech Sciences
College Park, Maryland, 20742
Samira B Anderson, PhD
Michael A Johns, PhD
- Recruiting
Maryland Neuroimaging Center
College Park, Maryland, 20742
Sandy Collier
Stefanie Kuchinsky, PhD
About this study
Official title: Auditory-cognitive Training Paradigm (NIH P01 Project - Speech Perception With High Cognitive Demand)
With advancing age, adults experience increasing speech understanding difficulties in challenging situations. Currently, speech-in-noise difficulties are rehabilitated by providing hearing aids. For older normal-hearing adults, however, hearing devices do not provide much benefit since these adults do not have decreased hearing sensitivity. The goal of the "Speech Perception and High Cognitive Demand" project is to evaluate the benefit of a new auditory-cognitive training paradigm. In the present study neural (as measured by pupillometry and magnetoencephalography) and behavioral changes of speech-in-noise perception from pretest to posttest will be examined in older adults (age 65 - 85 years) assigned to one of three training groups: 1) Active Control Group: sessions of watching informational videos, 2) Auditory Training Group: sessions of auditory training listening to one of two speakers in everyday scenarios (e.g., driving directions) and needing to recall what one speaker said in the previous sentence, and 3) Auditory-cognitive training group: identical to the auditory training group, except participants will be asked to remember information from two previous sentences. Changes in speech-in-noise perception will be examined for the three groups of older adults and gains will be compared to a control group of young, normal hearing adults (18-30 years) that is not part of the clinical trial and will not undergo any training.
Read the detailed description
With advancing age, adults experience increasing difficulties in understanding speech in challenging situations, such as difficulty with understanding others in a noisy restaurant. Speech-in-noise difficulties are typically rehabilitated by providing hearing aids. For older normal-hearing adults, however, hearing devices do not provide much benefit since these adults do not have decreased hearing sensitivity. For these adults, communication difficulties persist in everyday life situations and can even lead to social withdrawal, isolation, and depression. A growing body of studies demonstrates that combined auditory-cognitive training paradigms can offer speech-in-noise benefits to adults with hearing loss that could prevent the consequences listed above.
The goal of the "Speech Perception with High Cognitive Demand" project is to evaluate the benefit of a new auditory-cognitive training paradigm for older normal-hearing adults. The investigators developed an American English version of the Nottingham (UK) PLUS training paradigm in which listeners are asked to focus and listen to one speaker while ignoring another speaker. Although it cannot ensure that every participant will experience direct significant benefit from the training, the paradigm is being designed to optimally enhance the possibility of benefit: an adaptive procedure is employed to train each individual at their own level and to make the task challenging. In a separate training condition, a short-term memory component is added to the original training paradigm to also enhance the cognitive skills of the participants. In addition, the training is implemented on touch-screen laptops, making at-home training possible. This way, training is provided in a realistic setting which will ensure a better transfer of the trained skills to daily communication situations. The trial consists of three conditions: 1) Auditory only training, 2) Auditory-cognitive training, and 3) Active control of informational videos.
- Conditions
- Speech Intelligibility, Aging
- Being tested
- Auditory-cognitive training paradigm, Auditory training paradigm
- Keywords
- Auditory-cognitive training, Aging, Speech-in-noise perception
- Medical subject headings
- Speech Intelligibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory-cognitive training paradigmBehavioural
The investigators developed an American English version of the Nottingham (UK) PLUS training paradigm in which listeners are asked to focus and listen to one speaker while ignoring another speaker. The paradigm is designed to optimally enhance the possibility of benefit: an adaptive procedure is employed to train each individual at their own level to make the task challenging. A short-term memory component, in which listeners are asked to remember what a designated speaker said two sentences prior, was added to the auditory training paradigm to make the task more challenging. Participants will be asked to recall the keywords of the to-be-attended speaker. The sentences will be presented in a two-down one-up adaptive procedure in which the ratio of the levels of the to-be-attended and to-be-ignored speaker will be adjusted based on the correctly recalled key words.
Auditory training paradigmBehavioural
The investigators developed an American English version of the Nottingham (UK) PLUS training paradigm in which listeners are asked to focus and listen to one speaker while ignoring another speaker. The paradigm is designed to optimally enhance the possibility of benefit: an adaptive procedure is employed to train each individual at their own level to make the task challenging. Participants will be asked to recall the keywords of the to-be-attended speaker. The sentences will be presented in a two-down one-up adaptive procedure in which the ratio of the levels of the to-be-attended and to-be-ignored speaker will be adjusted based on the correctly recalled key words.
| Study group | Role | What they receive |
|---|---|---|
| Auditory training paradigm | Experimental | Participants perform speech-in-noise perception tasks with real-world scenarios. Receives: Behavioral: Auditory training paradigm |
| Auditory-cognitive training paradigm | Experimental | Participants perform speech-in-noise perception tasks with real-world scenarios. A short-term memory component is added to the training paradigm to make the task more engaging and challenging. Receives: Behavioral: Auditory-cognitive training paradigm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in speech-in-noise perception
In the Quick Speech-in-noise task (QSIN). Participants listen to a target female speaker in babble across six sentences (i.e., one list) presented at different signal-to-noise ratios (SNRs). Each sentence has five target words that participants are asked to repeat at the end of each sentence. Within each list, the first sentence is played with a 25 dB SNR and SNR decreases as the list progresses in increments of 5 dB., with the final sentence played at 0 dB. The average SNR score is calculated across several lists. The average SNR score is calculated across several lists. Scores range from -4.5 to 25.5 dB. Higher scores indicate greater SNR loss (i.e., worse hearing).
Measured: Week 1-2 (pretest) and Week 5-6 (posttest)
Audiobook - Change in pupillary response
During an audiobook listening task, pupil dilations are recorded as an objective measure of listening effort, with larger pupil dilations indicating increased listening effort. Change in pupil dilations at pre and posttest (before and after training, respectively) will be measured. In the audiobook listening task, audiobook segments will be presented to participants at signal-to-noise ratios (SNRs) of quiet, 0 dB, -6 dB, and in babble (with four background speakers). Participants listen to each audiobook segment three times.
Measured: Week 1-2 (pretest) and Week 5-6 (posttest)
Audiobook - Change in magnetoencephalography (MEG) temporal response function
During an audiobook listening task, MEG neural activity will be recorded. The investigators will evaluate change in the temporal response function (TRF). The TRF relates how the brain responds to acoustic stimuli and can be viewed as evoked responses to the continuous speech. Audiobook segments will be presented to participants at signal-to-noise ratios (SNRs) of quiet, 0 dB, -6 dB, and in babble (with four background speakers). Participants listen to each audiobook segment three times.
Measured: Week 1-2 (pretest) and Week 5-6 (posttest)
Change in Magnetoencephalography (MEG) stimulus reconstruction accuracies and integration window analysis
During an audiobook listening task, MEG neural activity will be recorded. The investigators will measure how far the neural response tracks the speech stimulus by stimulus reconstruction accuracies and how the stimulus reconstruction accuracy builds up over time by integration window analysis. Audiobook segments will be presented to participants at signal-to-noise ratios (SNRs) of quiet, 0 dB, -6 dB, and in babble (with four background speakers). Participants listen to each audiobook segment three times.
Measured: Week 1-2 (pretest) and Week 5-6 (posttest)
Audiobook - Change in frequency following response (FFR)
During an audiobook listening task, MEG neural activity will be recorded. The investigators will measure change in the FFR. The FFR is a measure of neural activity in response to a sound and serves as a measure of neural sound encoding. Larger FFR amplitudes indicate greater representations of an auditory stimulus. Audiobook segments will be presented to participants at signal-to-noise ratios (SNRs) of quiet, 0 dB, -6 dB, and in babble (with four background speakers). Participants listen to each audiobook segment three times and after each repetition.
Measured: Week 1-2 (pretest) and Week 5-6 (posttest)
Audiobook - Change in Magnetoencephalography (MEG) network localized granger causality
During an audiobook listening task MEG neural activity will be recorded. The investigators will measure the network localized granger causality (NLGC) to measure the networked activity of the cortex. Audiobook segments will be presented to participants at signal-to-noise ratios (SNRs) of quiet, 0 dB, -6 dB, and in babble (with four background speakers). Participants listen to each audiobook segment three times and after each repetition.
Measured: Week 1-2 (pretest) and Week 5-6 (posttest)
Secondary outcomes (6)
Audiobook - Change in subjective ratings
During an audiobook listening task, participants provide subjective listening effort and speech intelligibility ratings. This is an experimenter-generated measure. Audiobook segments will be presented to participants at signal-to-noise ratios (SNRs) of quiet, 0 dB, -6 dB, and in babble (with four background speakers). Participants listen to each audiobook segment three times and after each triad of audiobook segments, participants answer subjective intelligibility and listening effort questions. Scores are on a scale from 0 to 10 in increments of 1. Higher subjective intelligibility ratings indicate easier intelligibility whereas higher listening effort indicates more listening effort was exerted while listening to the audiobook segments.
Measured: Week 1-2 (pretest) and Week 5-6 (posttest)
Tone cloud - Change in auditory stream segregation accuracy
As a measure of change in auditory stream segregation, participants complete a stochastic figure-ground (SFG) task, in which participants listen to inharmonious 50 ms tones with random onsets for six seconds. For half of these stimuli, a figure "pops-out" from the background tones, in which a number of tones begin at the same time, making a chord. This figure chord repeats 12 times over the course of three seconds. Participants indicate when they detect a figure chord. The stimuli that contain the figure chord have chords consisting of 4, 6, or 8 tones. Figure detection accuracy will be calculated as percent correct for each figure chord condition.
Measured: Week 1-2 (pretest) and Week 5-6 (posttest)
Tone cloud - Change in auditory stream segregation reaction time (RT)
As a measure of change in auditory stream segregation, participants complete a stochastic figure-ground (SFG) task, in which participants listen to inharmonious 50 ms tones with random onsets for six seconds. For half of these stimuli, a figure "pops-out" from the background tones, in which a number of tones begin at the same time, making a chord. This figure chord repeats 12 times over the course of three seconds. Participants indicate when they detect a figure chord. The stimuli that contain the figure chord have chords consisting of 4, 6, or 8 tones. RT to the figure present stimuli will be calculated as average RT for each figure chord condition.
Measured: Week 1-2 (pretest) and Week 5-6 (posttest)
N-back task - Change in accuracy
Because the auditory and auditory-cognitive training paradigms involve a working memory component, pre and posttests of an n-back working memory measure are included. Participants complete four blocks in which they listen to a string of letters spoken by a female speaker. Participants are asked to click a button when a letter occurred n-back. Each block increases in the nth element that needs to be remember, starting at n = 1 (Block 1) and ending at n = 4 (Block 4). Participants' accuracy as percent correct are averaged for each level of n.
Measured: Week 1-2 (pretest) and Week 5-6 (posttest)
N-back task - Change in response time (RT)
Because the auditory and auditory-cognitive training paradigms involve a working memory component, pre and posttests of an n-back working memory measure are included. Participants complete four blocks in which they listen to a string of letters spoken by a female speaker. Participants are asked to click a button when a letter occurred n-back. Each block increases in the nth element that needs to be remember, starting at n = 1 (Block 1) and ending at n = 4 (Block 4). Participants' RTs for correct hits are measured and averaged for each level of n.
Measured: Week 1-2 (pretest) and Week 5-6 (posttest)
Reading Span (RSpan) - Change in working memory (WM)
Pre and posttests of an RSpan working memory measure are included. Participants read sets of short sentences consisting of 3, 4, 5, or 6 words per sentence. Half of the sentences are anomalous, and the other half are not. Participants are asked to read each sentence aloud one word at a time and then indicate whether the sentence made semantic sense or not. At the end of each set, participants are asked to remember the last word of each sentence, in order, to the best of their ability. Set sizes increase as the task progresses. Everyone starts with a set size of three words per sentence and ends at a set size of six words per sentence; there are three sentences for each set size. The final score is based on the total number of words recalled. Scores range from 0 to 54, with higher scores indicating better performance.
Measured: Week 1-2 (pretest) and Week 5-6 (posttest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start27 Sep 2021
- Primary completion30 May 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Speech IntelligibilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Jonathan Simon, University of Maryland, College Park
- Investigators
- Samira B Anderson, PhD, Principal investigator, University of Maryland, College ParkJonathan Z Simon, PhD, Principal investigator, University of Maryland, College ParkStefanie E Kuchinsky, PhD, Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997577
- Sponsor's protocol ID
- P01AG055365
- Other IDs
- 5P01AG055365-04
- Status last verified
- Apr 2025
- First submitted
- 16 Jul 2021
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to use the Digital Repository at the University of Maryland (DRUM) platform for data storage and sharing.
Publications
Ferguson MA, Henshaw H. Auditory training can improve working memory, attention, and communication in adverse conditions for adults with hearing loss. Front Psychol. 2015 May 28;6:556. doi: 10.3389/fpsyg.2015.00556. eCollection 2015.
PubMed 26074826Lawrence BJ, Jayakody DMP, Henshaw H, Ferguson MA, Eikelboom RH, Loftus AM, Friedland PL. Auditory and Cognitive Training for Cognition in Adults With Hearing Loss: A Systematic Review and Meta-Analysis. Trends Hear. 2018 Jan-Dec;22:2331216518792096. doi: 10.1177/2331216518792096.
PubMed 30092719
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auditory-cognitive Training Paradigm (NIH P01 Project - Speech Perception With High Cognitive Demand)
- ClinicalTrials.gov ID
- NCT04997577
- Acronym / sponsor ID
- P01AG055365
- Conditions
- Speech Intelligibility, Aging
- Keywords
- Auditory-cognitive training, Aging, Speech-in-noise perception
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With advancing age, adults experience increasing speech understanding difficulties in challenging situations. Currently, speech-in-noise difficulties are rehabilitated by providing hearing aids. For older normal-hearing adults, however, hearing devices do not provide much benefit since these adults do not have decreased hearing sensitivity. The goal of the "Speech Perception and High Cognitive Demand" project is to evaluate the benefit of a new auditory-cognitive training paradigm. In the present study neural (as measured by pupillometry and magnetoencephalography) and behavioral changes of speech-in-noise perception from pretest to posttest will be examined in older adults (age 65 - 85 years) assigned to one of three training groups: 1) Active Control Group: sessions of watching informational videos, 2) Auditory Training Group: sessions of auditory training listening to one of two speakers in everyday scenarios (e.g., driving directions) and needing to recall what one speaker said in the previous sentence, and 3) Auditory-cognitive training group: identical to the auditory training group, except participants will be asked to remember information from two previous sentences. Changes in speech-in-noise perception will be examined for the three groups of older adults and gains will be compared to a control group of young, normal hearing adults (18-30 years) that is not part of the clinical trial and will not undergo any training.
Detailed description
With advancing age, adults experience increasing difficulties in understanding speech in challenging situations, such as difficulty with understanding others in a noisy restaurant. Speech-in-noise difficulties are typically rehabilitated by providing hearing aids. For older normal-hearing adults, however, hearing devices do not provide much benefit since these adults do not have decreased hearing sensitivity. For these adults, communication difficulties persist in everyday life situations and can even lead to social withdrawal, isolation, and depression. A growing body of studies demonstrates that combined auditory-cognitive training paradigms can offer speech-in-noise benefits to adults with hearing loss that could prevent the consequences listed above.
The goal of the "Speech Perception with High Cognitive Demand" project is to evaluate the benefit of a new auditory-cognitive training paradigm for older normal-hearing adults. The investigators developed an American English version of the Nottingham (UK) PLUS training paradigm in which listeners are asked to focus and listen to one speaker while ignoring another speaker. Although it cannot ensure that every participant will experience direct significant benefit from the training, the paradigm is being designed to optimally enhance the possibility of benefit: an adaptive procedure is employed to train each individual at their own level and to make the task challenging. In a separate training condition, a short-term memory component is added to the original training paradigm to also enhance the cognitive skills of the participants. In addition, the training is implemented on touch-screen laptops, making at-home training possible. This way, training is provided in a realistic setting which will ensure a better transfer of the trained skills to daily communication situations. The trial consists of three conditions: 1) Auditory only training, 2) Auditory-cognitive training, and 3) Active control of informational videos.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auditory training paradigm | Experimental | Behavioral: Auditory training paradigmParticipants perform speech-in-noise perception tasks with real-world scenarios. |
| Auditory-cognitive training paradigm | Experimental | Behavioral: Auditory-cognitive training paradigmParticipants perform speech-in-noise perception tasks with real-world scenarios. A short-term memory component is added to the training paradigm to make the task more engaging and challenging. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Aged between 65 - 85 years
- Normal hearing (pure tone thresholds ≤ 25 dB HL from 250 - 8000 Hz)
- Self-reported normal or corrected-to-normal vision
- Dominant language: American English
- Education: a high school diploma or higher education level
Key exclusion criteria (10 listed)
- Middle-ear or inner-ear pathology
- Non-native speaker of English
- Inability to complete all training sessions within a pre-specified time window (e.g., due to unexpected schedule restrictions)
- Learning disorders
- Metal in body that induces a data artifact for MEG recording (e.g., excessive metal dental work) or that poses a safety issue in the MRI portion (e.g., pacemakers, neural implants, metal plates or joints, shrapnel, and surgical staples)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory-cognitive training paradigmThe investigators developed an American English version of the Nottingham (UK) PLUS training paradigm in which listeners are asked to focus and listen to one speaker while ignoring another speaker. The paradigm is designed to optimally enhance the possibility of benefit: an adaptive procedure is employed to train each individual at their own level to make the task challenging. A short-term memory component, in which listeners are asked to remember what a designated speaker said two sentences prior, was added to the auditory training paradigm to make the task more challenging. Participants will be asked to recall the keywords of the to-be-attended speaker. The sentences will be presented in a two-down one-up adaptive procedure in which the ratio of the levels of the to-be-attended and to-be-ignored speaker will be adjusted based on the correctly recalled key words. | Behavioural | Auditory-cognitive training paradigm |
| Auditory training paradigmThe investigators developed an American English version of the Nottingham (UK) PLUS training paradigm in which listeners are asked to focus and listen to one speaker while ignoring another speaker. The paradigm is designed to optimally enhance the possibility of benefit: an adaptive procedure is employed to train each individual at their own level to make the task challenging. Participants will be asked to recall the keywords of the to-be-attended speaker. The sentences will be presented in a two-down one-up adaptive procedure in which the ratio of the levels of the to-be-attended and to-be-ignored speaker will be adjusted based on the correctly recalled key words. | Behavioural | Auditory training paradigm |
Primary outcome
Change in speech-in-noise perception
Time frame: Week 1-2 (pretest) and Week 5-6 (posttest)
In the Quick Speech-in-noise task (QSIN). Participants listen to a target female speaker in babble across six sentences (i.e., one list) presented at different signal-to-noise ratios (SNRs). Each sentence has five target words that participants are asked to repeat at the end of each sentence. Within each list, the first sentence is played with a 25 dB SNR and SNR decreases as the list progresses in increments of 5 dB., with the final sentence played at 0 dB. The average SNR score is calculated across several lists. The average SNR score is calculated across several lists. Scores range from -4.5 to 25.5 dB. Higher scores indicate greater SNR loss (i.e., worse hearing).
Audiobook - Change in pupillary response
Time frame: Week 1-2 (pretest) and Week 5-6 (posttest)
During an audiobook listening task, pupil dilations are recorded as an objective measure of listening effort, with larger pupil dilations indicating increased listening effort. Change in pupil dilations at pre and posttest (before and after training, respectively) will be measured. In the audiobook listening task, audiobook segments will be presented to participants at signal-to-noise ratios (SNRs) of quiet, 0 dB, -6 dB, and in babble (with four background speakers). Participants listen to each audiobook segment three times.
Audiobook - Change in magnetoencephalography (MEG) temporal response function
Time frame: Week 1-2 (pretest) and Week 5-6 (posttest)
During an audiobook listening task, MEG neural activity will be recorded. The investigators will evaluate change in the temporal response function (TRF). The TRF relates how the brain responds to acoustic stimuli and can be viewed as evoked responses to the continuous speech. Audiobook segments will be presented to participants at signal-to-noise ratios (SNRs) of quiet, 0 dB, -6 dB, and in babble (with four background speakers). Participants listen to each audiobook segment three times.
Change in Magnetoencephalography (MEG) stimulus reconstruction accuracies and integration window analysis
Time frame: Week 1-2 (pretest) and Week 5-6 (posttest)
During an audiobook listening task, MEG neural activity will be recorded. The investigators will measure how far the neural response tracks the speech stimulus by stimulus reconstruction accuracies and how the stimulus reconstruction accuracy builds up over time by integration window analysis. Audiobook segments will be presented to participants at signal-to-noise ratios (SNRs) of quiet, 0 dB, -6 dB, and in babble (with four background speakers). Participants listen to each audiobook segment three times.
Audiobook - Change in frequency following response (FFR)
Time frame: Week 1-2 (pretest) and Week 5-6 (posttest)
During an audiobook listening task, MEG neural activity will be recorded. The investigators will measure change in the FFR. The FFR is a measure of neural activity in response to a sound and serves as a measure of neural sound encoding. Larger FFR amplitudes indicate greater representations of an auditory stimulus. Audiobook segments will be presented to participants at signal-to-noise ratios (SNRs) of quiet, 0 dB, -6 dB, and in babble (with four background speakers). Participants listen to each audiobook segment three times and after each repetition.
Audiobook - Change in Magnetoencephalography (MEG) network localized granger causality
Time frame: Week 1-2 (pretest) and Week 5-6 (posttest)
During an audiobook listening task MEG neural activity will be recorded. The investigators will measure the network localized granger causality (NLGC) to measure the networked activity of the cortex. Audiobook segments will be presented to participants at signal-to-noise ratios (SNRs) of quiet, 0 dB, -6 dB, and in babble (with four background speakers). Participants listen to each audiobook segment three times and after each repetition.
6 secondary outcomes
Audiobook - Change in subjective ratings
Time frame: Week 1-2 (pretest) and Week 5-6 (posttest)
Tone cloud - Change in auditory stream segregation accuracy
Time frame: Week 1-2 (pretest) and Week 5-6 (posttest)
Tone cloud - Change in auditory stream segregation reaction time (RT)
Time frame: Week 1-2 (pretest) and Week 5-6 (posttest)
N-back task - Change in accuracy
Time frame: Week 1-2 (pretest) and Week 5-6 (posttest)
N-back task - Change in response time (RT)
Time frame: Week 1-2 (pretest) and Week 5-6 (posttest)
Reading Span (RSpan) - Change in working memory (WM)
Time frame: Week 1-2 (pretest) and Week 5-6 (posttest)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Background: PubMed 26074826Ferguson MA, Henshaw H. Auditory training can improve working memory, attention, and communication in adverse conditions for adults with hearing loss. Front Psychol. 2015 May 28;6:556. doi: 10.3389/fpsyg.2015.00556. eCollection 2015.
- Background: PubMed 30092719Lawrence BJ, Jayakody DMP, Henshaw H, Ferguson MA, Eikelboom RH, Loftus AM, Friedland PL. Auditory and Cognitive Training for Cognition in Adults With Hearing Loss: A Systematic Review and Meta-Analysis. Trends Hear. 2018 Jan-Dec;22:2331216518792096. doi: 10.1177/2331216518792096.
- Individual participant dataSharing planned: Yes. Plan to use the Digital Repository at the University of Maryland (DRUM) platform for data storage and sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samira B Anderson, PhD principal investigator
University of Maryland, College Park
Jonathan Z Simon, PhD principal investigator
University of Maryland, College Park
Stefanie E Kuchinsky, PhD principal investigator
Walter Reed National Military Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory-cognitive training paradigm and Auditory training paradigm in people with Speech Intelligibility and Aging, run by University of Maryland, College Park at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Z Simon, PhD (301-405-3645, jzsimon@umd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in speech-in-noise perception (time frame: Week 1-2 (pretest) and Week 5-6 (posttest)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04997577, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.