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Tracking Biomarkers of Speech Intelligibility

Primary Purpose

High-Frequency Hearing Loss

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Video Game Training Group 1
Video Game Training Group 2
Sponsored by
Massachusetts Eye and Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for High-Frequency Hearing Loss

Eligibility Criteria

40 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Sham Comparator

    Sham Comparator

    Arm Label

    Video Game Training Group 1 - High Frequency Hearing Loss

    Video Game Training Group 1 - Normal Hearing

    Video Game Training Group 2 - High Frequency Hearing Loss

    Video Game Training Group 2 - Normal Hearing

    Arm Description

    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.

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

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Change in the neural encoding fidelity for frequency modulated tones
    EEG phase coherence to a 500 Hz tone modulated at variable depths at 2Hz.
    Change in the psychophysical frequency modulation detection threshold
    Frequency modulation detection threshold of 500 Hz carrier modulated at 2Hz.
    Increase in pupil dilation while listening to sentences in noise
    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.

    Full Information

    First Posted
    September 29, 2021
    Last Updated
    November 23, 2021
    Sponsor
    Massachusetts Eye and Ear Infirmary
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05145946
    Brief Title
    Tracking Biomarkers of Speech Intelligibility
    Official Title
    Neural Pathophysiology and Suprathreshold Processing in Older Adults With Elevated Thresholds
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2022 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts Eye and Ear Infirmary

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    High-Frequency Hearing Loss

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Video Game Training Group 1 - High Frequency Hearing Loss
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Video Game Training Group 1 - Normal Hearing
    Arm Type
    Active Comparator
    Arm Description
    Closed-loop audiomotor game. Home-based training sessions for 3.5 hours per week over an 8-week. Participants will have normal hearing.
    Arm Title
    Video Game Training Group 2 - High Frequency Hearing Loss
    Arm Type
    Sham Comparator
    Arm Description
    Auditory memory game. Home-based training sessions for 3.5 hours per week over an 8-week. Participants will have high frequency hearing loss.
    Arm Title
    Video Game Training Group 2 - Normal Hearing
    Arm Type
    Sham Comparator
    Arm Description
    Auditory memory game. Home-based training sessions for 3.5 hours per week over an 8-week. Participants will have normal hearing.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Video Game Training Group 1
    Intervention Description
    Closed-loop audiomotor game. Home-based training sessions for 3.5 hours per week over an 8-week.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Video Game Training Group 2
    Intervention Description
    Auditory memory game. Home-based training sessions for 3.5 hours per week over an 8-week.
    Primary Outcome Measure Information:
    Title
    Change in Speech Recognition in Noise Performance Accuracy
    Description
    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.
    Time Frame
    Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)
    Secondary Outcome Measure Information:
    Title
    Change in the neural encoding fidelity for frequency modulated tones
    Description
    EEG phase coherence to a 500 Hz tone modulated at variable depths at 2Hz.
    Time Frame
    Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)
    Title
    Change in the psychophysical frequency modulation detection threshold
    Description
    Frequency modulation detection threshold of 500 Hz carrier modulated at 2Hz.
    Time Frame
    Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)
    Title
    Increase in pupil dilation while listening to sentences in noise
    Description
    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.
    Time Frame
    Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    69 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jenna Browning-Kamins, Au.D.
    Phone
    617-573-6001
    Email
    hearingrehab@meei.harvard.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniel B Polley, Ph.D.
    Organizational Affiliation
    Massachusetts Eye and Ear Infirmary
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Tracking Biomarkers of Speech Intelligibility

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