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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04698356
Other study ID # P01AG055365
Secondary ID P01AG055365
Status Completed
Phase N/A
First received
Last updated
Start date April 9, 2021
Est. completion date July 31, 2021

Study information

Verified date May 2023
Source University of Maryland, College Park
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date July 31, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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 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.

Locations

Country Name City State
United States Department of Hearing and Speech Sciences College Park Maryland

Sponsors (2)

Lead Sponsor Collaborator
University of Maryland, College Park National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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