Speech IntelligibilityNCT04698356
Speech Perception With High Cognitive Demand
A study testing Auditory-cognitive training paradigm in people with Speech Intelligibility and Aging, run by University of Maryland, College Park at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Speech Intelligibility, Aging
- What is being tested?
- Auditory-cognitive training paradigm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2021to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Hearing and Speech Sciences
College Park, Maryland, 20742
About this study
Official title: Pilot Study - Validation of Speech Materials for an Auditory-cognitive Training Paradigm (NIH P01 Project - Speech Perception With High Cognitive Demand)
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.
- Conditions
- Speech Intelligibility, Aging
- Being tested
- Auditory-cognitive training paradigm
- Keywords
- Auditory-cognitive training, Aging, Speech-in-noise perception
- Medical subject headings
- Speech Intelligibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory-cognitive training paradigmBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Auditory-cognitive training paradigm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start9 Apr 2021
- Primary completion30 Jun 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speech IntelligibilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Joe Smith, University of Maryland, College Park
- Investigators
- Samira B Anderson, PhD, Principal investigator, University of Maryland, College ParkJonathan Z Simon, PhD, Principal investigator, University of Maryland, College ParkStefanie E Kuchinsky, PhD, Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698356
- Sponsor's protocol ID
- P01AG055365
- Other IDs
- P01AG055365
- Status last verified
- May 2023
- First submitted
- 23 Dec 2020
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Promotheus
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study - Validation of Speech Materials for an Auditory-cognitive Training Paradigm (NIH P01 Project - Speech Perception With High Cognitive Demand)
- ClinicalTrials.gov ID
- NCT04698356
- Acronym / sponsor ID
- P01AG055365
- Conditions
- Speech Intelligibility, Aging
- Keywords
- Auditory-cognitive training, Aging, Speech-in-noise perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Validation of auditory-cognitive training paradigm | Experimental | Behavioral: Auditory-cognitive training paradigmIn 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory-cognitive training paradigmThe 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. | Behavioural | Validation of auditory-cognitive training paradigm |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Individual participant dataSharing planned: Yes. Promotheus
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory-cognitive training paradigm in people with Speech Intelligibility and Aging, run by University of Maryland, College Park at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech reception threshold (SRT) (time frame: Through study completion, an average of 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023; AzTrials last refreshed its copy on 27 Oct 2026.