Speech Perception With High Cognitive Demand
Pilot Study - Validation of Speech Materials for an Auditory-cognitive Training Paradigm (NIH P01 Project - Speech Perception With High Cognitive Demand)
1 other identifier
interventional
15
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2021
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
January 6, 2021
CompletedStudy Start
First participant enrolled
April 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2021
CompletedMay 30, 2023
May 1, 2023
3 months
December 23, 2020
May 25, 2023
Conditions
Keywords
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
EXPERIMENTALIn 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.
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.
Eligibility Criteria
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
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
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