NCT04698356

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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

December 23, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 9, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

December 23, 2020

Last Update Submit

May 25, 2023

Conditions

Keywords

Auditory-cognitive trainingAgingSpeech-in-noise perception

Outcome Measures

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).

    Through study completion, an average of 2 months

Study Arms (1)

Validation of auditory-cognitive training paradigm

EXPERIMENTAL

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

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.

Validation of auditory-cognitive training paradigm

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hearing and Speech Sciences

College Park, Maryland, 20742, United States

Location

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director - HRPP (L. Decruy is no longer at UMD)

Study Record Dates

First Submitted

December 23, 2020

First Posted

January 6, 2021

Study Start

April 9, 2021

Primary Completion

June 30, 2021

Study Completion

July 31, 2021

Last Updated

May 30, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

Promotheus

Locations