Skip to main content
Clinical Trials/NCT04997577
NCT04997577
Recruiting
Not Applicable

Auditory-cognitive Training Paradigm (NIH P01 Project - Speech Perception With High Cognitive Demand)

University of Maryland, College Park2 sites in 1 country100 target enrollmentSeptember 27, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Speech Intelligibility
Sponsor
University of Maryland, College Park
Enrollment
100
Locations
2
Primary Endpoint
Audiobook - Change in magnetoencephalography (MEG) temporal response function
Status
Recruiting
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 27, 2021
End Date
December 31, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jonathan Simon

Professor

University of Maryland, College Park

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

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.

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) 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.

Secondary Outcomes

  • 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))
  • Reading Span (RSpan) - Change in working memory (WM)(Week 1-2 (pretest) and Week 5-6 (posttest))
  • Audiobook - Change in subjective ratings(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))
  • N-back task - Change in accuracy(Week 1-2 (pretest) and Week 5-6 (posttest))

Study Sites (2)

Loading locations...

Similar Trials