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Tracking Biomarkers of Speech Intelligibility

NCT ID: NCT05145946

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-31

Study Completion Date

2022-12-31

Brief Summary

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Difficulties understanding speech in noisy environments repeatedly coincide with high-frequency hearing loss. This complaint is commonly exhibited in adults in middle/older age who have a history of noise exposure. In this study, an immersive audiomotor training game will be utilized to drive improvements in speech intelligibility, controlled by an auditory memory training game. Physiological measures will be tracked that could inform clinical assessment of hearing in noise abilities.

Detailed Description

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Hearing loss is a chronic health disorder affecting approximately 15 percent of Americans. High-frequency hearing loss can be imperceptible when listening in quiet environments. However, in complex noisy environments, individuals can severely suffer from an inability to resolve speech. This is despite having normal audiometric thresholds in the low-frequency range within which speech signals are contained. There are several factors that could contribute to speech intelligibility difficulties that are imperceptible with typical hearing tests. These include impaired temporal encoding at the auditory nerve and the downstream sequelae of peripheral damage in the central auditory pathway. The goal of this study is to assess how a set of physiological measures of auditory/neural processing map onto suprathreshold hearing outcomes.

In a previous study, significant improvements in speech intelligibility have resulted from training on an immersive video game. The game uses a closed-loop audiomotor interface design that reinforces sensory-guided feedback. As a control, an auditory memory training game has been developed to replicate user expectations and procedural learning. In this study, an audiomotor game and control game will be used as mechanisms through which to track changes to physiological and perceptual biomarkers in a high frequency hearing loss cohort and a matched normal hearing cohort. Tests will be run pre-training, post- training, and at a follow-up point.

Conditions

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High-Frequency Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Video Game Training Group 1 - High Frequency Hearing Loss

Closed-loop audiomotor game. Home-based training sessions for 3.5 hours per week over an 8-week. Participants will have high frequency hearing loss.

Group Type EXPERIMENTAL

Video Game Training Group 1

Intervention Type BEHAVIORAL

Closed-loop audiomotor game. Home-based training sessions for 3.5 hours per week over an 8-week.

Video Game Training Group 1 - Normal Hearing

Closed-loop audiomotor game. Home-based training sessions for 3.5 hours per week over an 8-week. Participants will have normal hearing.

Group Type ACTIVE_COMPARATOR

Video Game Training Group 1

Intervention Type BEHAVIORAL

Closed-loop audiomotor game. Home-based training sessions for 3.5 hours per week over an 8-week.

Video Game Training Group 2 - High Frequency Hearing Loss

Auditory memory game. Home-based training sessions for 3.5 hours per week over an 8-week. Participants will have high frequency hearing loss.

Group Type SHAM_COMPARATOR

Video Game Training Group 2

Intervention Type BEHAVIORAL

Auditory memory game. Home-based training sessions for 3.5 hours per week over an 8-week.

Video Game Training Group 2 - Normal Hearing

Auditory memory game. Home-based training sessions for 3.5 hours per week over an 8-week. Participants will have normal hearing.

Group Type SHAM_COMPARATOR

Video Game Training Group 2

Intervention Type BEHAVIORAL

Auditory memory game. Home-based training sessions for 3.5 hours per week over an 8-week.

Interventions

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Video Game Training Group 1

Closed-loop audiomotor game. Home-based training sessions for 3.5 hours per week over an 8-week.

Intervention Type BEHAVIORAL

Video Game Training Group 2

Auditory memory game. Home-based training sessions for 3.5 hours per week over an 8-week.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* High frequency hearing loss subjects - Thresholds of 15 dB HL or less for 0.25-2 kHz. Thresholds of 30-60 dB HL from 3-8 kHz.
* Normal hearing subjects - Thresholds of 15 dB HL or less from 0.5-8 kHz.
* Thresholds between left and right ears symmetric within 10 dB for all frequencies.
* Native English speakers.

Exclusion Criteria

* Conductive hearing loss (as assessed by audiologist).
* Active otologic disease (as assessed by audiologist).
* Significant cognitive decline (Montreal Cognitive Assessment score \> 25).
Minimum Eligible Age

40 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role lead

Responsible Party

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Daniel Brandon Polley

Daniel Polley, Professor in Department of Otology and Laryngology, Massachusetts Eye and Ear Infirmary

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel B Polley, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Eye and Ear Infirmary

Other Identifiers

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pending_090721

Identifier Type: -

Identifier Source: org_study_id