- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01867515
Spectral Dynamics and Speech Understanding by Hearing Impaired People
April 24, 2018 updated by: VA Office of Research and Development
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- VA Portland Health Care System, Portland, OR
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Younger normally-hearing listeners
Participants with auditory thresholds within the normal limits.
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|
|
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
|
|
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Active Comparator: Older normally-hearing listeners
Participants with auditory thresholds within the normal limits.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
average of two blocks per condition obtained over the course of up to three 2-hour visits, spaced an average of one week apart
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michelle R Molis, PhD, VA Portland Health Care System, Portland, OR
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
May 20, 2013
First Submitted That Met QC Criteria
May 29, 2013
First Posted (Estimate)
June 4, 2013
Study Record Updates
Last Update Posted (Actual)
April 26, 2018
Last Update Submitted That Met QC Criteria
April 24, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C1020-R
- 5I01RX001020-03 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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