- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05954520
Effects of Nonlinear Signal Processing Algorithms on Speech Perception
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this study, we are interested in how nonlinear algorithms influence speech perception.
Nonlinear algorithms are used within hearing aids and personal sound amplifiers to provide comfort to the listener. One of these algorithms provides amplification (gain) in a manner that depends on the level of the input sound.: Low-level sounds are amplified much more than high-level sounds. This type of amplification makes sounds more comfortable for listeners, but also distorts incoming sounds. To determine the effect of these algorithms on speech understanding, we will evaluate the following factors on speech perception, within the context of these algorithms:
- The input Signal-to-Noise ratio (SNR) to the algorithm (3 different SNRs)
- The type of background noise (20 people talking or 2 people talking)
- Algorithm settings (slow and fast - whether changes to gain applied to fluctuating input sounds occurs quickly or slowly)
To address our questions, we are using a wearable processor (Tympan) that allows for real-time processing of audio signals. The Tympan itself contains microphones, a processor, and small earpieces that include speakers. A listener can wear the earpieces, like headphones, and listen to sounds processed by the Tympan in real time. The Tympan allows us access to the algorithms and to the sounds processed by the algorithms so that we cannot algorithm behavior to speech perception.
Our study will complement existing work on speech perception and nonlinear algorithms, but our study will be the first to use a wearable processor in which the specific algorithm is known, tailored to an individual's hearing levels, and which allows for direct calculation of the output SNR. Most studies also have not measured speech perception, and this will be one of only a handful of studies with that objective.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
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Bloomington, Indiana, United States, 47408
- Health Sciences Building
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Between the ages of 18 and 65
- Native speaker of English
- Have bilateral, symmetric sensorineural hearing loss that is less than 75 decibels (dB) Hearing Level (HL) at 1000 Hz and below.
Exclusion Criteria:
- Subjects with normal hearing, mixed hearing loss, or asymmetric sensorineural hearing loss.
- Subjects who younger than 18 or older than 65.
- Subjects who are not native speakers of English.
- Subjects with thresholds more than 70 dB HL at 2000 Hz and below
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Perceptual measures
Perception will be measured for different algorithm settings and environmental variables (type of noise and signal-to-noise ratio)
|
Participants will wear a prototype hearing aid (called the Tympan)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Speech understanding
Time Frame: 1-2 hours
|
Percent words correct will be measured
|
1-2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preference
Time Frame: 15 minutes
|
Algorithm preference will be measured for each experimental condition
|
15 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18675
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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