Mediators and Moderators of Auditory Training

NCT06812273 | Recruiting

• 1 other identifier: 22066
• Study Type: interventional
• Target: 1,260
• Locations: 1 country
• Sites: 3

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.

Conditions

Hearing Handicap

Keywords

audition; auditory training; cognition

Outcome Measures

Primary Outcomes (3)

• Digits-in-Noise (DIN) Task

  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)

  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)

  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 Outcomes (2)

• Revised Hearing Handicap Inventory (RHHI)

  Pre-test (day 3), mid-test (day 20), post-test (day 36), follow-up (day 66)

• Auditory Visual Divided Attention Test (AVDAT)

  Pretest (day 3), post-test (day 36), follow-up (day 66)

Study Arms (6)

STM Training

EXPERIMENTAL

Behavioral: STM Training

Speech Training

EXPERIMENTAL

Behavioral: Speech Training

Mixed Training

EXPERIMENTAL

Behavioral: Mixed Training

Gamified Training

EXPERIMENTAL

Behavioral: Gamified Training

Foraging Training

EXPERIMENTAL

Behavioral: Foraging Training

Business As Usual

NO INTERVENTION

Interventions

STM Training BEHAVIORAL

This condition consists of an up/down spectral-temporal modulations (STM) presented both in quiet and with competing background noise

STM Training

Speech Training BEHAVIORAL

Participants will train on the identification of three sets of speech stimuli of increasing linguistic complexity: individual phonemes (vowels), spondaic words, and matrix sentences.

Speech Training

Mixed Training BEHAVIORAL

This condition involves both the STM and the speech training, described above, and an additional module training localization.

Mixed Training

Gamified Training BEHAVIORAL

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.

Gamified Training

Foraging Training BEHAVIORAL

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.

Foraging Training

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Northeastern University: lead
• Oregon Health and Science University: collaborator
• University of California, Riverside: collaborator

Study Sites (3)

University of California, Riverside

Riverside, California, 92521, United States

RECRUITING

Northeastern University

Boston, Massachusetts, 02115, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Study Officials

• Aaron Seitz, PhD

  Northeastern University

  PRINCIPAL INVESTIGATOR

• Tess Koerner, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Audrey Carrillo, M.A.

CONTACT

626-482-8091; a.carrillo@northeastern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology, Game Design, and Physical Therapy, Movement and Rehabilitation Services

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 6, 2025
• Study Start: January 6, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: Data will be available persistently at the conclusion of the study.
• Access Criteria: There are no access criteria.

Locations

US (3)