Back to resultsHearing Study: Sensitivity to Features of Speech Sounds
Primary Purpose
Hearing Loss, Sensorineural
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Signal processing to improve intelligibility
Sponsored by
About this trial
This is an interventional basic science trial for Hearing Loss, Sensorineural
Eligibility Criteria
Inclusion Criteria:
- Normal hearing, mild or moderate symmetric sensorineural hearing loss.
Exclusion Criteria:
- Asymmetric hearing thresholds (more than 15 decibels (dB) threshold difference between the two ears at any frequency up to 4 kHz).
- Severe hearing loss (greater than 60 dB hearing thresholds at any frequency up to 4 kHz).
Sites / Locations
- University of RochesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Normal Hearing
Mild hearing loss
Moderate hearing loss
Arm Description
Signal processing to improve intelligibility
Signal processing to improve intelligibility
Signal processing to improve intelligibility
Outcomes
Primary Outcome Measures
Discrimination thresholds for formant-freq difference limens
Measures of discrimination thresholds (in units of "% of Formant Frequency" at the discrimination threshold) for different formant bandwidths and for different alignments of formants and harmonics.
Secondary Outcome Measures
% of correct synthetic vowels
% correct answers
% of correct synthetic syllables
% correct answers
% of correct words
% correct answers using SPiN test
Full Information
NCT ID
NCT03666676
First Posted
September 8, 2018
Last Updated
October 8, 2022
Sponsor
University of Rochester
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT03666676
Brief Title
Hearing Study: Sensitivity to Features of Speech Sounds
Official Title
Auditory Processing of Complex Sounds - Sensitivity to Chirps
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2020 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to better understand the sensitivity of listeners to the fast changes in frequency or amplitude of sounds that occur in speech. The investigators are studying ways to manipulate these aspects of sounds in an effort to make speech sounds more clear.
Detailed Description
The investigators will test listeners with normal hearing or with mild or moderate hearing loss. Tests will first focus on sensitivity to changes in fast changes in amplitude (loudness) or frequency (pitch) in sounds. Then the investigators will test the intelligibility of synthetic vowels and syllables in which these "chirps" are manipulated. Finally, the investigators will test intelligibility of words in noise while manipulating sounds in an effort to improve clarity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Normal Hearing
Arm Type
Active Comparator
Arm Description
Signal processing to improve intelligibility
Arm Title
Mild hearing loss
Arm Type
Active Comparator
Arm Description
Signal processing to improve intelligibility
Arm Title
Moderate hearing loss
Arm Type
Active Comparator
Arm Description
Signal processing to improve intelligibility
Intervention Type
Other
Intervention Name(s)
Signal processing to improve intelligibility
Intervention Description
Signal processing will be used to manipulate frequency and amplitude fluctuations in complex sounds.
Primary Outcome Measure Information:
Title
Discrimination thresholds for formant-freq difference limens
Description
Measures of discrimination thresholds (in units of "% of Formant Frequency" at the discrimination threshold) for different formant bandwidths and for different alignments of formants and harmonics.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
% of correct synthetic vowels
Description
% correct answers
Time Frame
5 years
Title
% of correct synthetic syllables
Description
% correct answers
Time Frame
5 years
Title
% of correct words
Description
% correct answers using SPiN test
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Normal hearing, mild or moderate symmetric sensorineural hearing loss.
Exclusion Criteria:
Asymmetric hearing thresholds (more than 15 decibels (dB) threshold difference between the two ears at any frequency up to 4 kHz).
Severe hearing loss (greater than 60 dB hearing thresholds at any frequency up to 4 kHz).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurel H Carney
Phone
5852763948
Email
laurel.carney@rochester.edu
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurel Carney
Phone
585-276-3948
Email
laurel.carney@rochester.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hearing Study: Sensitivity to Features of Speech Sounds
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