CClinicalTrials.gg
CompletedNCT04698356Updated May 30, 2023

Speech Perception With High Cognitive Demand

An interventional study of Auditory-cognitive training paradigm in Speech Intelligibility and Aging, sponsored by University of Maryland, College Park. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-30.

Sponsored by University of Maryland, College Park · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 30 Years
Sex
All
01

Study 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 a decreased hearing sensitivity. The goal of the "Speech Perception with High Cognitive Demand" Project is to evaluate the benefit of a new auditory-cognitive training paradigm. In order to provide maximal benefit for older, normal-hearing adults, a validation of the new training materials is required. In a pilot study, the investigators will evaluate the new auditory-cognitive training paradigm in 15 young, normal-hearing adults (18-30 years). Based on these results, the training paradigm can be further optimized for older adults.

Read the detailed description

With advancing age, adults experience increasing speech understanding difficulties in challenging situations, such as difficulty with understanding other persons 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 a 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 (Ferguson \& Henshaw, 2015; Lawrence et al., 2018). 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 ensured 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 in order to train each individual at their own level and to make the task challenging, and 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 tablets rather than computers, making at-home training possible (many older adults are more comfortable with tablets than laptops). This way, not only the risk of COVID-19 for participants is minimized, but training is also provided in a realistic setting which will ensure a better transfer of the trained skills to daily communication situations.

In order to provide maximal benefit for older, normal-hearing adults, a validation of the new training materials is however required, and the initial validation will be for younger adults only. The investigators will evaluate the translated and adjusted sentences (from UK to American English), the adaptive procedure, and the short-term memory component, in young, normal-hearing adults (18-30 years). Based on the results of this pilot study, the sentences and procedures of the training paradigm can be further optimized for older adults.

02

Conditions studied

  • Speech Intelligibility
  • Aging

Keywords

  • Auditory-cognitive training
  • Aging
  • Speech-in-noise perception
03

In context

Lead sponsor

University of Maryland, College Park is the lead sponsor of 60 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age between 18-30 years
  • Normal hearing (pure-tone thresholds \<= 25 dB HL from 250-8000 Hz)
  • Dominant language: American English
  • Education: a high school diploma or higher educational level

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    Validation of auditory-cognitive training paradigm

    In order to provide maximal speech-in-noise training benefit for older, normal-hearing adults, a validation of our new training materials is required. The investigators will evaluate the translated and adjusted sentences (based on the Nottingham UK PLUS training paradigm), the adaptive procedure, and the short-term memory component, in young, normal-hearing adults (18-30 years). Based on the results of this pilot study, the investigators can further optimize the sentences and procedures to be used during the training paradigm for older adults.

    Behavioral: Auditory-cognitive training paradigm

Interventions

  • BehavioralAuditory-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 in order to train each individual at their own level and to make the task challenging. A short-term memory component was also added to the original training paradigm, to enhance the cognitive skills of our participants. To provide maximal speech-in-noise benefit for older, normal-hearing adults, a validation of our new training materials is required. The investigators will evaluate this in young, normal-hearing adults (18-30 years) by studying our outcome measure (speech reception threshold) for the different sentence-scenarios and test-retest sessions.

06

What researchers measure

Primary outcomes

  1. Speech reception threshold (SRT)

    Sentences of seven different scenarios will be presented to young, normal-hearing adults. Participants will be instructed to listen to one speaker and ignore the other one, will be asked to recall the keywords of the to-be-attended sentence after the target sentence (0-back) or after the next sentence was presented (1-back; short-term memory component). The sentences will be presented using an 2 down-1up 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 keywords. This means that the procedure will converge to a level-ratio for which the participant understands 71% of the to-be-attended speaker, also called the speech reception threshold (SRT). The SRT will be used to compare the 0-back versus 1-back task and the validity of the different scenarios/sentences and procedures (mean/median SRT, inter- and intrasubject variability of the scenarios and test-retest session).

    Time frame: Through study completion, an average of 2 months

07

Study locations

1 site
  • Department of Hearing and Speech Sciences
    College Park, Maryland 20742, United States
08

References and documents

Individual participant data

Plan to share: Yes — Promotheus

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04698356
Lead sponsor
University of Maryland, College Park
Collaborators
National Institute on Aging (NIA)
Responsible party
Joe Smith (Director - HRPP (L. Decruy is no longer at UMD), University of Maryland, College Park) — Principal investigator
First posted
Jan 6, 2021
Start date
Apr 9, 2021
Primary completion
Jun 30, 2021
Completion
Jul 31, 2021
Last update
May 30, 2023

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion