Mediators and Moderators of Auditory Training

NCT ID: NCT06812273

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-06
• Study Completion Date: 2027-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

STM Training

Group Type: EXPERIMENTAL

STM Training

Intervention Type: BEHAVIORAL

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

Speech Training

Group Type: EXPERIMENTAL

Speech Training

Intervention Type: 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.

Mixed Training

Group Type: EXPERIMENTAL

Mixed Training

Intervention Type: BEHAVIORAL

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

Gamified Training

Group Type: EXPERIMENTAL

Gamified Training

Intervention Type: 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.

Foraging Training

Group Type: EXPERIMENTAL

Foraging Training

Intervention Type: 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.

Business As Usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

STM Training

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Mixed Training

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

University of California, Riverside

OTHER

Sponsor Role: collaborator

Northeastern University

OTHER

Sponsor Role: lead

Responsible Party

Aaron Seitz

Professor of Psychology, Game Design, and Physical Therapy, Movement and Rehabilitation Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aaron Seitz, PhD

Role: PRINCIPAL_INVESTIGATOR

Northeastern University

Tess Koerner, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

University of California, Riverside

Riverside, California, United States

Site Status: RECRUITING

Northeastern University

Boston, Massachusetts, United States

Site Status: RECRUITING

Oregon Health & Science University

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Audrey Carrillo, M.A.

Role: CONTACT

a.carrillo@northeastern.edu

626-482-8091

Facility Contacts

Audrey Carrillo

Role: primary

a.carrillo@northeastern.edu

Audrey Carrillo, M.A.

Role: primary

a.carrillo@northeastern.edu

Lauren Charney

Role: primary

charneyl@ohsu.edu

503-494-5375

Other Identifiers

22066

Identifier Type: -

Identifier Source: org_study_id