Mediators and Moderators of Auditory Training

Not Applicable

Recruiting

• Conditions: Hearing Handicap

• Registration Number: NCT06812273
• Lead Sponsor: Northeastern University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-06
• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-01-31
• Last Update Submitted: 2025-01-31
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06
• Primary Completion: 2027-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1260

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Digits-in-Noise (DIN) Task	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.
Spatial Release From Masking (SRM)	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.
Dichotic Sentence Identification (DSI)	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.

Secondary Outcome Measures

Name	Time	Method
Revised Hearing Handicap Inventory (RHHI)	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.
Auditory Visual Divided Attention Test (AVDAT)	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.

Trial Locations

Locations (3)

University of California, Riverside; 🇺🇸 Riverside, California, United States

Northeastern University; 🇺🇸 Boston, Massachusetts, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States