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PC-Based Rehabilitation of Auditory Function (CINT)

Primary Purpose

Hearing Loss, Sensorineural

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Consonant Identification Training
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hearing Loss, Sensorineural focused on measuring Auditory Perception, Hearing Loss, Presbycusis, Perceptual Learning, Hearing Prosthesis, Speech Discrimination, Delayed Treatment

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Older subjects with normal hearing.
  • Older subjects with mild sensorineural hearing loss who have recently received hearing aids.
  • Some young subjects with normal hearing for developing training paradigms.

Exclusion Criteria:

  • Health problems that would preclude training.
  • Dementia.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Arm 1

    Arm Description

    Hearing impaired listeners with hearing aids underwent two months of consonant identification training in their homes.

    Outcomes

    Primary Outcome Measures

    .Speech Discrimination Ability
    Mean consonant identification threshold improvement measure in z-scores (re normal hearing subjects) on consonant and sentence discrimination tests. Additional computerized tests measured auditory short-term verbal memory, and auditory pattern discrimination. The results were compared with baseline performance in the listener group as well as performance in other older hearing impaired subjects who used hearing aids, but who did not undergo training. In the next month, we will published two manuscripts in PLoS ONE describing (1) the benefits of hearing aids on speech comprehension in the absence of perceptual training; (2) the additional benefits of perceptual training. More metholdological details can be found in those manuscripts.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 24, 2008
    Last Updated
    January 15, 2015
    Sponsor
    US Department of Veterans Affairs
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00724347
    Brief Title
    PC-Based Rehabilitation of Auditory Function
    Acronym
    CINT
    Official Title
    PC-based Rehabilitation of Auditory Function
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2008 (undefined)
    Primary Completion Date
    March 2013 (Actual)
    Study Completion Date
    March 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    US Department of Veterans Affairs

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Many older subjects experience difficulty in understanding speech in noisy environments. Part of this problem is related to changes that occur in the ear with age and compromise the hearing of high-pitched sounds. Another part of the problem with speech understanding relates to changes with age in the neural circuits of the brain that process different speech sounds. Evidence suggests that these changes in neural circuits are particularly large if hearing loss is present. Thus, while hearing aids may help compensate for hearing deficits by amplifying speech sounds, additional treatment is necessary to restore optimal neural connections in the brain so that speech sounds can be accurately distinguished from each other. We are developing PC-based training programs in an attempt to restore optimal neural connections. The current randomized trial will evaluate whether two months of training to improve the ability to discriminate different consonant sounds in noise will also improve the understanding of continuous speech and enhance auditory memory and other high-level auditory functions.
    Detailed Description
    More than 300,000 veterans with sensorineural hearing loss (SNHL) are fitted with VA-issued hearing aids (HAs) each year with the primary goal of improving their understanding of speech. Even older veterans without hearing loss experience a gradual decline in speech discrimination due to age-related changes in auditory function that compromise speech understanding in everyday environments. Neuroplastic reorganization within the central auditory system due to SNHL and aging contribute to these effects and compromise subjects' ability to process phonetic cues that are essential for understanding speech in noise. As a consequence, even when a HA restores high frequency signals to the cochlea in a patient with SNHL, speech understanding will remain suboptimal in the absence of rehabilitative perceptual learning. We have developed perceptual learning paradigms that drive this rehabilitative reorganization and significantly improve speech discrimination in new HA users. We now propose to test improved training paradigms in new and experienced HA users and older subjects with normal hearing. In Exp. 1 we will evaluate baseline speech discrimination in these populations using speech-reception thresholds (SRTs) in sentences, consonant-vowel-consonant nonsense syllable tests (CVC-NST), tests of tone-pattern discrimination, and tests of auditory short-term verbal memory (ASTVM). An analysis of the correlations of these measures will provide information about basic processes underlying impaired word and sentence identification. In Exp. 2 we will investigate the effects of CVC-identification training using performance-adapted masking noise. Based on our previous results, we anticipate that training will significantly improve CVC-NST scores. We will examine the extent to which training improves SRTs, tone-pattern processing, and ASTVM. In Exp. 3 we will train subjects in a tone-pattern identification task to evaluate the extent to which non-phonetic factors (e.g., familiarity with the computerized hearing tests, placebo effects of training, improvements in auditory attention, etc.) may contribute to training benefit. In Exp. 4 we will compare the benefits of training with single-consonant syllables with the benefits of two-consonant syllable training studied in Exp. 2. Finally, in Exp. 5 we will study the benefits of CVC training using consonant-specific noise levels adjusted to compensate for intrinsic differences in the discriminability of different consonants and compare them to the benefits of global adaptive training from Exp. 2. The experiments will clarify fundamental mechanisms underlying deficits in speech discrimination and ASTVM, provide insight into the nature of training-related improvements, and elucidate the parameters needed to optimize hearing rehabilitation. Relevance to the VA patient care mission: HAs are relatively ineffective in improving the ability of hearing-impaired subjects to understand speech in many everyday listening situations. These experiments will clarify the extent to which perceptual training can improve speech discrimination and enhance ASTVM in these conditions in new and experienced HA users and older subjects with normal hearing. Perceptual training could potentially benefit millions of veterans who wear HAs as well as older veterans with normal hearing who experience difficulties in understanding and remembering speech.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hearing Loss, Sensorineural
    Keywords
    Auditory Perception, Hearing Loss, Presbycusis, Perceptual Learning, Hearing Prosthesis, Speech Discrimination, Delayed Treatment

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1
    Arm Type
    Experimental
    Arm Description
    Hearing impaired listeners with hearing aids underwent two months of consonant identification training in their homes.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Consonant Identification Training
    Intervention Description
    Subjects received psychophysically adaptive, consonant identification training in consonant discrimination on PCs in their homes.
    Primary Outcome Measure Information:
    Title
    .Speech Discrimination Ability
    Description
    Mean consonant identification threshold improvement measure in z-scores (re normal hearing subjects) on consonant and sentence discrimination tests. Additional computerized tests measured auditory short-term verbal memory, and auditory pattern discrimination. The results were compared with baseline performance in the listener group as well as performance in other older hearing impaired subjects who used hearing aids, but who did not undergo training. In the next month, we will published two manuscripts in PLoS ONE describing (1) the benefits of hearing aids on speech comprehension in the absence of perceptual training; (2) the additional benefits of perceptual training. More metholdological details can be found in those manuscripts.
    Time Frame
    Subjects will receive two months of PC training and be tested before and after 2-months of training with speech tests in the laboratory..

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    78 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Older subjects with normal hearing. Older subjects with mild sensorineural hearing loss who have recently received hearing aids. Some young subjects with normal hearing for developing training paradigms. Exclusion Criteria: Health problems that would preclude training. Dementia.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David L. Woods, PhD
    Organizational Affiliation
    VA Northern California HCS
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23341320
    Citation
    Woods DL, Doss Z, Herron TJ, Yund EW. Age-related changes in consonant and sentence processing. J Rehabil Res Dev. 2012;49(8):1277-91. doi: 10.1682/jrrd.2011.08.0150.
    Results Reference
    result
    PubMed Identifier
    20329860
    Citation
    Woods DL, Yund EW, Herron TJ, Ua Cruadhlaoich MA. Consonant identification in consonant-vowel-consonant syllables in speech-spectrum noise. J Acoust Soc Am. 2010 Mar;127(3):1609-23. doi: 10.1121/1.3293005.
    Results Reference
    result
    PubMed Identifier
    20665350
    Citation
    Woods DL, Yund EW, Herron TJ. Measuring consonant identification in nonsense syllables, words, and sentences. J Rehabil Res Dev. 2010;47(3):243-60. doi: 10.1682/jrrd.2009.04.0040.
    Results Reference
    result
    PubMed Identifier
    20562624
    Citation
    Yund EW, Woods DL. Content and procedural learning in repeated sentence tests of speech perception. Ear Hear. 2010 Dec;31(6):769-78. doi: 10.1097/AUD.0b013e3181e68e4a.
    Results Reference
    result

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    PC-Based Rehabilitation of Auditory Function

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