Clinical trial NCT06812273: Mediators and Moderators of Auditory Training
Official title: Mediators and Moderators of Auditory Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Handicap
Keywords: audition
auditory training
cognition
Lead sponsor: Northeastern University
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: University of California, Riverside
First posted: 2025-02-06
Enrollment: 1260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Digits-in-Noise (DIN) Task
timeFrame: Pre-test (day 3), mid-test (day 20), post-test (day 36), follow-up (day 66)
measure: Spatial Release From Masking (SRM)
timeFrame: Pre-test (day 3), mid-test (day 20), post-test (day 36), follow-up (day 66)
measure: Dichotic Sentence Identification (DSI)
timeFrame: Pre-test (day 3), mid-test (day 20), post-test (day 36), follow-up (day 66)
Secondary outcomes:
measure: Revised Hearing Handicap Inventory (RHHI)
timeFrame: Pre-test (day 3), mid-test (day 20), post-test (day 36), follow-up (day 66)
measure: Auditory Visual Divided Attention Test (AVDAT)
timeFrame: Pretest (day 3), post-test (day 36), follow-up (day 66)
Other outcomes:
Locations:
city: Riverside
country: United States
facility: University of California, Riverside
state: California
city: Boston
country: United States
facility: Northeastern University
state: Massachusetts
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Northeastern University
name: Aaron Seitz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Tess Koerner, PhD
role: PRINCIPAL_INVESTIGATOR
References: