NCT04997577

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Sep 2021Dec 2027

First Submitted

Initial submission to the registry

July 16, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 27, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

4.7 years

First QC Date

July 16, 2021

Last Update Submit

April 3, 2025

Conditions

Keywords

Auditory-cognitive trainingAgingSpeech-in-noise perception

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

EXPERIMENTAL

Participants perform speech-in-noise perception tasks with real-world scenarios.

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.

Behavioral: Auditory-cognitive training paradigm

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.

Auditory-cognitive training paradigm

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.

Auditory training paradigm

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

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

RECRUITING

Maryland Neuroimaging Center

College Park, Maryland, 20742, United States

RECRUITING

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: 26074826BACKGROUND
  • Lawrence 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

Speech Intelligibility

Condition Hierarchy (Ancestors)

SpeechVerbal BehaviorCommunicationBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Z Simon, PhD

CONTACT

Michael A Johns, PhD

CONTACT

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

Plan to use the Digital Repository at the University of Maryland (DRUM) platform for data storage and sharing.

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
Within one year of end of study completion
Access Criteria
no restrictions

Locations