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Spectral Dynamics and Speech Understanding by Hearing Impaired People

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ClinicalTrials.gov Identifier: NCT01867515
Recruitment Status : Completed
First Posted : June 4, 2013
Results First Posted : April 26, 2018
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE May 20, 2013
First Posted Date  ICMJE June 4, 2013
Results First Submitted Date  ICMJE September 1, 2017
Results First Posted Date  ICMJE April 26, 2018
Last Update Posted Date April 26, 2018
Study Start Date  ICMJE August 2013
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2018)
Percent Correct Words Identified [ Time Frame: average of two blocks per condition obtained over the course of up to three 2-hour visits, spaced an average of one week apart ]
The experimental approach compares speech identification performance among younger, normally-hearing listeners, older normally-hearing listeners and hearing-impaired listeners. Tasks will be carried out in quiet and in the presence of continuous, speech-shaped background noise. The investigators compared the understanding of unprocessed stimuli with 1) time-compressed stimuli, 2) time-compressed stimuli expanded in time via gaps and 3) uncompressed stimuli where portions of the signal were replaced with silence. Experimental metrics were percentage of correct/incorrect speech identification in each listening condition.
Original Primary Outcome Measures  ICMJE
 (submitted: May 29, 2013)
Perception of spectral change in speech [ Time Frame: Three years ]
The experimental approach compares speech identification performance among normal hearing listeners, hearing-impaired listeners, and normal hearing listeners with simulated hearing impairment. Tasks will be carried out in quiet and in the presence of 2 levels of continuous, speech-shaped background noise. Experimental metrics will be percentage of correct/incorrect speech identification and patterns of response confusions. Error rates and error patterns will be compared among the three listener groups. Performance will also be interpreted relative to the output of a computational model.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2013)
Speech understanding of signals with targeted spectral change enhancement [ Time Frame: Three years ]
The experimental approach compares speech identification performance among normal hearing listeners, hearing-impaired listeners, and normal hearing listeners with simulated hearing impairment for stimuli that have been enhanced in the frequency region of the second formant. Tasks will be carried out in quiet and in the presence of two levels of continuous, speech-shaped background noise. Experimental metrics will be percentage of correct/incorrect speech identification and patterns of response confusions.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spectral Dynamics and Speech Understanding by Hearing Impaired People
Official Title  ICMJE Spectral Dynamics and Speech Understanding by Hearing Impaired People
Brief Summary The purpose of this program of research is to understand the perception of the dynamic spectral properties of speech by hearing-impaired listeners, with the long-term goal of improving speech understanding by these individuals in adverse listening conditions. The proposed research compares the performance of normally-hearing and hearing-impaired listeners on measures of speech understanding in the presence of different types of signal distortion and speech understanding of signals with enhanced spectral dynamics. A computational model based on the amount of potential information available in speech will be used to quantify differences in speech intelligibility due to hearing status and stimulus characteristics.
Detailed Description This is a behavioral study of human auditory perception. Each experiment in this study involves prospective data collection from three types of listeners. The experimental listeners will be people with sensorineural hearing loss and the control listeners will either be subjects with normal hearing or normal-hearing listeners for whom hearing loss will be simulated through the use of a spectrally-shaped broadband noise. The tasks of the subjects in this study involve either listening to synthesized sounds over earphones while seated comfortably in a sound-treated booth, and making responses indicating the subject's auditory perception of these sounds by touching specific areas on a touch-screen terminal; or, listening to recorded, acoustically modified syllables, words, or sentences over earphones and making responses indicating the subject's identification.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Hearing Loss, Sensorineural
Intervention  ICMJE Other: Acoustic distortion of speech
Study Arms  ICMJE
  • Active Comparator: Younger normally-hearing listeners

    Participants with auditory thresholds within the normal limits.

    • age between 18 and 35
    • individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz Acoustic distortion of speech
    Intervention: Other: Acoustic distortion of speech
  • Active Comparator: Hearing-impaired listeners

    individuals with bilateral sensorineural hearing losses with thresholds between 25 and 70 dB HL and no losses greater than 70 dB HL at frequencies of 4000 Hz or below

    • age 18 to 65 Acoustic distortion of speech
    Intervention: Other: Acoustic distortion of speech
  • Active Comparator: Older normally-hearing listeners

    Participants with auditory thresholds within the normal limits.

    • age between 36 and 65
    • individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz Acoustic distortion of speech
    Intervention: Other: Acoustic distortion of speech
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2018)
50
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2013)
120
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz
  • or, individuals with bilateral sensorineural hearing losses with thresholds between 25 and 70 dB HL and no losses greater than 70 dB HL at frequencies of 4000 Hz or below

Exclusion Criteria:

  • a conductive hearing impairment or other otological pathology
  • hearing thresholds greater than 70 dB HL at any frequencies of 4000 Hz or below or pure-tone averages (averaged across 500, 1000, and 2000 Hz) of greater than 65 dB HL
  • bilateral differences greater than 20 dB at any frequency below 4000 Hz
  • an inability to complete the experimental tasks
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01867515
Other Study ID Numbers  ICMJE C1020-R
5I01RX001020-03 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michelle R Molis, PhD VA Portland Health Care System, Portland, OR
PRS Account VA Office of Research and Development
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP