Speech Perception and High Cognitive Demand
Auditory-cognitive Training Paradigm (NIH P01 Project - Speech Perception With High Cognitive Demand)
2 other identifiers
interventional
100
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2021
CompletedFirst Posted
Study publicly available on registry
August 9, 2021
CompletedStudy Start
First participant enrolled
September 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
April 8, 2025
April 1, 2025
4.7 years
July 16, 2021
April 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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).
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.
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.
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.
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.
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.
Week 1-2 (pretest) and Week 5-6 (posttest)
Secondary Outcomes (6)
Audiobook - Change in subjective ratings
Week 1-2 (pretest) and Week 5-6 (posttest)
Tone cloud - Change in auditory stream segregation accuracy
Week 1-2 (pretest) and Week 5-6 (posttest)
Tone cloud - Change in auditory stream segregation reaction time (RT)
Week 1-2 (pretest) and Week 5-6 (posttest)
N-back task - Change in accuracy
Week 1-2 (pretest) and Week 5-6 (posttest)
N-back task - Change in response time (RT)
Week 1-2 (pretest) and Week 5-6 (posttest)
- +1 more secondary outcomes
Study Arms (2)
Auditory training paradigm
EXPERIMENTALParticipants perform speech-in-noise perception tasks with real-world scenarios.
Auditory-cognitive training paradigm
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Hearing and Speech Sciences
College Park, Maryland, 20742, United States
Maryland Neuroimaging Center
College Park, Maryland, 20742, United States
Related Publications (2)
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.
PMID: 26074826BACKGROUNDLawrence 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.
PMID: 30092719BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samira B Anderson, PhD
University of Maryland, College Park
- PRINCIPAL INVESTIGATOR
Jonathan Z Simon, PhD
University of Maryland, College Park
- PRINCIPAL INVESTIGATOR
Stefanie E Kuchinsky, PhD
Walter Reed National Military Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will be unaware of the number and types of treatment groups.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 16, 2021
First Posted
August 9, 2021
Study Start
September 27, 2021
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
April 8, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
- Time Frame
- Within one year of end of study completion
- Access Criteria
- no restrictions
Plan to use the Digital Repository at the University of Maryland (DRUM) platform for data storage and sharing.