Training GroupEarly Phase 1NCT04921267
Impacts of Training on Effortful Listening
A Early Phase 1 study testing training in people with Training Group, run by Kansas State University at 1 site in United States.
Trial summary
Human listeners will hear speech masked by single-talker speech before and after auditory training. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Training Group
- What is being tested?
- training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2019to 31 May 2020
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normal hearing
Who cannot join
- hearing loss
Trial locations and contacts
1 site in 1 country.
About this study
Human listeners will hear speech masked by single-talker speech before and after auditory training.
Read the detailed description
Human listeners will hear speech masked by single-talker speech before and after auditory training. Training-related changes in EEG dynamics and behavioral measures of accuracy and effort will be assessed.
- Conditions
- Training Group
- Being tested
- training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trainingBehavioural
training with filtered speech
| Study group | Role | What they receive |
|---|---|---|
| trained group | Experimental | group receives training with sounds that correspond to simulated hearing protection Receives: Behavioral: training |
| Control | No intervention | group receives no training |
What is being measured
The primary outcome is the main question the study is designed to answer.
pretest EEG alpha power
power in the alpha-band
Measured: one day before training
posttest EEG alpha power
power in the alpha-band
Measured: one day after training
pretest accuracy
proportion correct for identifying speech
Measured: one day before training
posttest accuracy
proportion correct for identifying speech
Measured: one day after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start10 Oct 2019
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Training GroupStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups. One group is trained to listening through simulated hearing protection. The other receives no such training.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Wisniewski, Kansas State University
- Investigators
- Matthew Wisniewski, PhD, Principal investigator, Kansas State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921267
- Sponsor's protocol ID
- IRB9406
- Status last verified
- Jun 2021
- First submitted
- 11 Mar 2020
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of Training on Effortful Listening
- ClinicalTrials.gov ID
- NCT04921267
- Acronym / sponsor ID
- IRB9406
- Conditions
- Training Group
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Kansas State UniversityUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 10 Jun 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.
Human listeners will hear speech masked by single-talker speech before and after auditory training.
Detailed description
Human listeners will hear speech masked by single-talker speech before and after auditory training. Training-related changes in EEG dynamics and behavioral measures of accuracy and effort will be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 groups. One group is trained to listening through simulated hearing protection. The other receives no such training.
| Arm | Type | Receives |
|---|---|---|
| trained group | Experimental | Behavioral: traininggroup receives training with sounds that correspond to simulated hearing protection |
| Control | No intervention | –group receives no training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- normal hearing
Key exclusion criteria (1 listed)
- hearing loss
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 |
|---|---|---|
| trainingtraining with filtered speech | Behavioural | trained group |
Primary outcome
pretest EEG alpha power
Time frame: one day before training
power in the alpha-band
posttest EEG alpha power
Time frame: one day after training
power in the alpha-band
pretest accuracy
Time frame: one day before training
proportion correct for identifying speech
posttest accuracy
Time frame: one day after training
proportion correct for identifying speech
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 10 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Matthew Wisniewski, PhD principal investigator
Kansas State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing training in people with Training Group, run by Kansas State University 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 1 inclusion and 1 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 10 Jun 2021. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
pretest EEG alpha power (time frame: one day before training). The study lists 4 primary outcomes in all. 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 10 Jun 2021.