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Clinical Applications for Time-Compressed Speech Tests

Primary Purpose

Hearing Loss

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

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring Hearing Loss, Hearing Aids, Rehabilitation of hearing impaired

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants will be 50 to 75 years old.
  • Hearing loss will be limited to 40 dB HL from 250 Hz through 1000 Hz, and to 60 dB HL through 4000 Hz.
  • Hearing loss must be greater than 25 dB at two or more frequencies from 250 to 4000 Hz.

Exclusion Criteria:

  • None of the participants will be current or past hearing aid users; all will be free of ear disease.
  • Participants with conductive hearing losses, defined as air-bone gap greater than 15 dB, will be excluded.
  • The audiometric battery with acoustic reflex thresholds and decay measurements will be used to exclude anyone with evidence of a central disorder or a pathology other than a sensorineural loss. Those potential participants will be referred to a medical professional.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Mild Hearing Loss

    Moderate Hearing Loss

    Moderate-Severe Hearing Loss

    Arm Description

    Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz of 20-39 decibels hearing level (dBHL)

    Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz of 40-49 decibels hearing level (dBHL)

    Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz greater than 50 decibels hearing level (dBHL)

    Outcomes

    Primary Outcome Measures

    Ability to Understand Speech in Noise Background
    Measure speech perception for sentences in background noise

    Secondary Outcome Measures

    Full Information

    First Posted
    August 31, 2006
    Last Updated
    November 19, 2014
    Sponsor
    US Department of Veterans Affairs
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00371839
    Brief Title
    Clinical Applications for Time-Compressed Speech Tests
    Official Title
    Clinical Applications for Time-Compressed Speech Tests
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2006 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    December 2011 (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
    The purpose of this study is to determine the effects of age-related cognitive changes on hearing aid benefit based on hearing aid compression time constants. The hypothesis is that people with poor working memory skills will benefit from slow time constants in hearing aid compression while those with good working memory skills will be able to benefit from more sophisticated compression algorithms with rapid time constants.
    Detailed Description
    Recent research has shown the relevance of cognitive function in hearing aid evaluation and the sensitivity of the aging auditory system to temporal distortions. The proposed investigation will examine the interaction of working memory and hearing aid compression method on speech recognition in background competition for older listeners. This interaction will be investigated for the following three forms of background competition: Competition from continuous speech-shaped noise. Competition from speech-modulated noise. Competition from a single interfering talker. The goals of the study will be accomplished in two phases. In the first phase, 160 adults aged 50 through 75 years will be evaluated on a battery of tests to determine their cognitive capacity, time-compressed speech scores and their candidacy for inclusion in the second phase of the study. At the conclusion of this phase of testing, the participants will be divided into three groups: subjects with TCS test scores in the highest quartile (the HIGH group) subjects with TCS test scores in the lowest quartile (the LOW group) the remaining listeners The second phase of the experiment will include listeners from the HIGH and LOW groups only. These subjects will be evaluated with respect to their speech recognition ability for three types of interference (steady-state noise, speech-modulated noise, single interfering talker). The HINT test (Nilsson, Soli, & Sumida, 1995; Nilsson et al., 1994) will be used to obtain the signal-to-noise ratio (SNR) at 50% recognition for the three masking conditions for each of three types of amplification: one- channel linear amplification (LINEAR) with frequency shaping two-channel wide dynamic range compression with fast time constants (FAST) two-channel wide dynamic range compression with slow time constants (SLOW) Listener groups will be compared across hearing aid conditions and across background interference conditions.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hearing Loss
    Keywords
    Hearing Loss, Hearing Aids, Rehabilitation of hearing impaired

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    78 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mild Hearing Loss
    Arm Type
    Active Comparator
    Arm Description
    Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz of 20-39 decibels hearing level (dBHL)
    Arm Title
    Moderate Hearing Loss
    Arm Type
    Active Comparator
    Arm Description
    Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz of 40-49 decibels hearing level (dBHL)
    Arm Title
    Moderate-Severe Hearing Loss
    Arm Type
    Active Comparator
    Arm Description
    Audiological Evaluation will show average hearing threshold at 500, 1000, 2000, and 4000 Hz greater than 50 decibels hearing level (dBHL)
    Intervention Type
    Procedure
    Intervention Name(s)
    Audiological Evaluation
    Intervention Description
    Tests of hearing, cognition, and speech perception
    Primary Outcome Measure Information:
    Title
    Ability to Understand Speech in Noise Background
    Description
    Measure speech perception for sentences in background noise
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Participants will be 50 to 75 years old. Hearing loss will be limited to 40 dB HL from 250 Hz through 1000 Hz, and to 60 dB HL through 4000 Hz. Hearing loss must be greater than 25 dB at two or more frequencies from 250 to 4000 Hz. Exclusion Criteria: None of the participants will be current or past hearing aid users; all will be free of ear disease. Participants with conductive hearing losses, defined as air-bone gap greater than 15 dB, will be excluded. The audiometric battery with acoustic reflex thresholds and decay measurements will be used to exclude anyone with evidence of a central disorder or a pathology other than a sensorineural loss. Those potential participants will be referred to a medical professional.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marjorie R. Leek, PhD
    Organizational Affiliation
    VA Loma Linda Healthcare System, Loma Linda, CA
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.ncrar.research.va.gov/Index.asp
    Description
    This is the web page of the VA research Center where the study took place

    Learn more about this trial

    Clinical Applications for Time-Compressed Speech Tests

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