Study Stopped
Funding for this study ended prior to enrollment of any participants due to a change in funding.
Tracking Biomarkers of Speech Intelligibility
Neural Pathophysiology and Suprathreshold Processing in Older Adults With Elevated Thresholds
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
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.
Trial Health
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Started Jan 2022
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2021
CompletedFirst Posted
Study publicly available on registry
December 6, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedDecember 18, 2025
December 1, 2025
11 months
September 29, 2021
December 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Speech Recognition in Noise Performance Accuracy
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 Outcomes (3)
Change in the neural encoding fidelity for frequency modulated tones
Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)
Change in the psychophysical frequency modulation detection threshold
Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)
Increase in pupil dilation while listening to sentences in noise
Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)
Study Arms (4)
Video Game Training Group 1 - High Frequency Hearing Loss
EXPERIMENTALClosed-loop audiomotor game. Home-based training sessions for 3.5 hours per week over an 8-week. Participants will have high frequency hearing loss.
Video Game Training Group 1 - Normal Hearing
ACTIVE COMPARATORClosed-loop audiomotor game. Home-based training sessions for 3.5 hours per week over an 8-week. Participants will have normal hearing.
Video Game Training Group 2 - High Frequency Hearing Loss
SHAM COMPARATORAuditory memory game. Home-based training sessions for 3.5 hours per week over an 8-week. Participants will have high frequency hearing loss.
Video Game Training Group 2 - Normal Hearing
SHAM COMPARATORAuditory memory game. Home-based training sessions for 3.5 hours per week over an 8-week. Participants will have normal hearing.
Interventions
Closed-loop audiomotor game. Home-based training sessions for 3.5 hours per week over an 8-week.
Auditory memory game. Home-based training sessions for 3.5 hours per week over an 8-week.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Conductive hearing loss (as assessed by audiologist).
- Active otologic disease (as assessed by audiologist).
- Significant cognitive decline (Montreal Cognitive Assessment score \> 25).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel B Polley, Ph.D.
Massachusetts Eye and Ear Infirmary
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Daniel Polley, Professor in Department of Otology and Laryngology, Massachusetts Eye and Ear Infirmary
Study Record Dates
First Submitted
September 29, 2021
First Posted
December 6, 2021
Study Start
January 1, 2022
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
December 18, 2025
Record last verified: 2025-12