- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06812273
Mediators and Moderators of Auditory Training
The goal of this clinical trial is to learn how Auditory Training (AT) may help people better understand speech in noisy environments. As people get older, it becomes harder for them to hear speech clearly when there is background noise. This can be frustrating, and it can affect their independence and quality of life. AT is often used to support people with and without hearing loss, especially when a person is not a good candidate for a hearing aid or when amplification from a hearing aid does not improve performance.
The investigators want to gather reliable data to understand how AT works and what affects its success.
The main questions the trial aims to answer are:
- How do different types of sounds influence the effectiveness of auditory training?
- Which auditory training approaches are most successful in improving speech understanding?
- How do personal traits impact the results of auditory training?
The investigators will study a large and diverse group of 1,260 participants, including both young and older adults, to evaluate various auditory training approaches.
You will:
- Take part in auditory training sessions that include different types of auditory tasks.
- Complete tests that measure how well they understand speech in both quiet and noisy settings.
- Complete surveys on personal data like demographics, hearing challenges and other factors to help researchers understand what might influence training results.
The investigators will measure and compare the results of these approaches to find out which ones are most effective. This could help people who are at risk of cognitive decline, like those at risk for Alzheimer's disease.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Audrey Carrillo, M.A.
- Phone Number: 626-482-8091
- Email: a.carrillo@northeastern.edu
Study Locations
-
-
California
-
Riverside, California, United States, 92521
- Recruiting
- University of California, Riverside
-
Contact:
- Audrey Carrillo
- Email: a.carrillo@northeastern.edu
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Northeastern University
-
Principal Investigator:
- Aaron Seitz, PhD
-
Contact:
- Audrey Carrillo, M.A.
- Email: a.carrillo@northeastern.edu
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health & Science University
-
Contact:
- Lauren Charney
- Phone Number: 503-494-5375
- Email: charneyl@ohsu.edu
-
Principal Investigator:
- Tess Koerner, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18-30 and 60-85 years of age.
- No self-reported auditory difficulties and normal or near-normal hearing sensitivity as measured by SRTs.
- Older adults aged 50-85 should have no more than typical hearing loss for their age and no evidence of dementia.
- Fluent in English and/or Spanish
Exclusion Criteria:
- Abnormal vision or hearing prohibitive of training
- History of seizures, focal brain lesion, or head injury with loss of consciousness
- Physical handicap (motor or perceptual) that would impede training procedures
- Medical illness requiring treatment during the study timeline
- Social, educational or economic hardship prohibitive to training schedule
- Concurrent enrollment in other cognitive training studies
- History of major psychiatric illness, including psychosis, bipolar disorder, depression, alcohol or substance abuse, recent bereavement
- Plans to travel out of the area for more than 1 week during the intervention period
- Residence too far from the testing site, which would prevent attending the testing sessions (> 60 miles)
- Not being proficient enough in English or Spanish that would prevent following and understanding all instructions and completing all testing sessions
Additional exclusion criteria for older adults:
- Diagnosis of dementia or other neurological disease, including mild cognitive impairment (MCI)
- Telephone-Montreal Cognitive Assessment (t-MoCA) score of 16 or less or Montreal Cognitive AssessmentMoCA) score of 20 or less
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: STM Training
|
This condition consists of an up/down spectral-temporal modulations (STM) presented both in quiet and with competing background noise
|
|
Experimental: Speech Training
|
Participants will train on the identification of three sets of speech stimuli of increasing linguistic complexity: individual phonemes (vowels), spondaic words, and matrix sentences.
|
|
Experimental: Mixed Training
|
This condition involves both the STM and the speech training, described above, and an additional module training localization.
|
|
Experimental: Gamified Training
|
This uses auditory training within a game experience where players control a game avatar (the "wisp") that appears to fly through a landscape.
Players were asked to help the wisp avoid obstacles or choose from among options based on a variety of sound cues.
|
|
Experimental: Foraging Training
|
This adds a component to the game where participants navigate the wisp to the location on the screen that relates to the target stimulus.
The concept here is that searching for targets with manual movements, ecologically stimulates sensori-motor loops where the actions of the participants generates the auditory stimuli that are heard.
|
|
No Intervention: Business As Usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Digits-in-Noise (DIN) Task
Time Frame: Pre-test (day 3), mid-test (day 20), post-test (day 36), follow-up (day 66)
|
The DIN tests the ability to identify a series of digits in varying levels of background noise.
|
Pre-test (day 3), mid-test (day 20), post-test (day 36), follow-up (day 66)
|
|
Spatial Release From Masking (SRM)
Time Frame: Pre-test (day 3), mid-test (day 20), post-test (day 36), follow-up (day 66)
|
Tests the ability to identify a target talker in the presence of competing speech signals that are either colocated or spatially separated from the target.
|
Pre-test (day 3), mid-test (day 20), post-test (day 36), follow-up (day 66)
|
|
Dichotic Sentence Identification (DSI)
Time Frame: Pre-test (day 3), mid-test (day 20), post-test (day 36), follow-up (day 66)
|
The DSI test simultaneously presents two nonsense sentences, one to each ear.
Participants indicate two sentences heard from a list of 10 alternatives.
|
Pre-test (day 3), mid-test (day 20), post-test (day 36), follow-up (day 66)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Revised Hearing Handicap Inventory (RHHI)
Time Frame: Pre-test (day 3), mid-test (day 20), post-test (day 36), follow-up (day 66)
|
The Revised Hearing Handicap Inventory (RHHI) is a self-assessment questionnaire designed to evaluate the perceived social and emotional effects of hearing loss on an individual's daily life.
|
Pre-test (day 3), mid-test (day 20), post-test (day 36), follow-up (day 66)
|
|
Auditory Visual Divided Attention Test (AVDAT)
Time Frame: Pretest (day 3), post-test (day 36), follow-up (day 66)
|
Auditory Visual Divided Attention Test (AVDAT) is a test of working memory that compares conditions when attention is to just a single modality (auditory or visual) or divided across modalities.
|
Pretest (day 3), post-test (day 36), follow-up (day 66)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aaron Seitz, PhD, Northeastern University
- Principal Investigator: Tess Koerner, PhD, Oregon Health and Science University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Other Study ID Numbers
- 22066
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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