- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04698356
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)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
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College Park, Maryland, United States, 20742
- Department of Hearing and Speech Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Speech reception threshold (SRT)
Time Frame: Through study completion, an average of 2 months
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P01AG055365 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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