- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03666676
Hearing Study: Sensitivity to Features of Speech Sounds
November 27, 2023 updated by: Laurel Carney, University of Rochester
Auditory Processing of Complex Sounds - Sensitivity to Chirps
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
200
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 Contact
- Name: Laurel H Carney
- Phone Number: 5852763948
- Email: laurel.carney@rochester.edu
Study Locations
-
-
New York
-
Rochester, New York, United States, 14642
- Recruiting
- University of Rochester
-
Contact:
- Laurel Carney
- Phone Number: 585-276-3948
- Email: laurel.carney@rochester.edu
-
-
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 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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).
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: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Normal Hearing
Signal processing to improve intelligibility
|
Signal processing will be used to manipulate frequency and amplitude fluctuations in complex sounds.
|
Active Comparator: Mild hearing loss
Signal processing to improve intelligibility
|
Signal processing will be used to manipulate frequency and amplitude fluctuations in complex sounds.
|
Active Comparator: Moderate hearing loss
Signal processing to improve intelligibility
|
Signal processing will be used to manipulate frequency and amplitude fluctuations in complex sounds.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Discrimination thresholds for formant-freq difference limens
Time Frame: 5 years
|
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.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
% of correct synthetic vowels
Time Frame: 5 years
|
% correct answers
|
5 years
|
% of correct synthetic syllables
Time Frame: 5 years
|
% correct answers
|
5 years
|
% of correct words
Time Frame: 5 years
|
% correct answers using SPiN test
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
June 9, 2020
Primary Completion (Estimated)
November 30, 2024
Study Completion (Estimated)
November 30, 2024
Study Registration Dates
First Submitted
September 8, 2018
First Submitted That Met QC Criteria
September 8, 2018
First Posted (Actual)
September 12, 2018
Study Record Updates
Last Update Posted (Actual)
November 28, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 73346
- R01DC001641 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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