Tracking Biomarkers of Speech Intelligibility

November 23, 2021 updated by: Daniel Brandon Polley, Massachusetts Eye and Ear Infirmary

Neural Pathophysiology and Suprathreshold Processing in Older Adults With Elevated Thresholds

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Video Game Training Group 1
Closed-loop audiomotor game. Home-based training sessions for 3.5 hours per week over an 8-week.
Active Comparator: 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.
Behavioral: Video Game Training Group 1
Closed-loop audiomotor game. Home-based training sessions for 3.5 hours per week over an 8-week.
Sham Comparator: 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.
Behavioral: Video Game Training Group 2
Auditory memory game. Home-based training sessions for 3.5 hours per week over an 8-week.
Sham Comparator: 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.
Behavioral: Video Game Training Group 2
Auditory memory game. Home-based training sessions for 3.5 hours per week over an 8-week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Speech Recognition in Noise Performance Accuracy
Time Frame: Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)
Keyword recognition accuracy for sentences in noise will be assessed with a clinical test, the QuickSiN. Signal to noise ratios vary from 25 to 0 dB in 5 dB steps.
Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the neural encoding fidelity for frequency modulated tones
Time Frame: Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)
EEG phase coherence to a 500 Hz tone modulated at variable depths at 2Hz.
Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)
Change in the psychophysical frequency modulation detection threshold
Time Frame: Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)
Frequency modulation detection threshold of 500 Hz carrier modulated at 2Hz.
Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)
Increase in pupil dilation while listening to sentences in noise
Time Frame: Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)
Growth in pupil dilation over the duration of the sentence will be measured while subjects perform the QuickSiN test at signal to noise ratios varying from 25 to 0 in 5 dB steps.
Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts Eye and Ear Infirmary

Investigators

  • Principal Investigator: Daniel B Polley, Ph.D., Massachusetts Eye and Ear Infirmary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

September 29, 2021

First Submitted That Met QC Criteria

November 23, 2021

First Posted (Actual)

December 6, 2021

Study Record Updates

Last Update Posted (Actual)

December 6, 2021

Last Update Submitted That Met QC Criteria

November 23, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pending_090721

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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