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Effects of Nonlinear Signal Processing Algorithms on Speech Perception

Primary Purpose

Speech, Hearing Loss, Sensorineural, Hearing Aids

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tympan
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Speech focused on measuring speech perception, hearing aids

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Health Sciences BuildingRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Perceptual measures

Arm Description

Perception will be measured for different algorithm settings and environmental variables (type of noise and signal-to-noise ratio)

Outcomes

Primary Outcome Measures

Speech understanding
Percent words correct will be measured

Secondary Outcome Measures

Preference
Algorithm preference will be measured for each experimental condition

Full Information

First Posted
July 13, 2023
Last Updated
August 24, 2023
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT05954520
Brief Title
Effects of Nonlinear Signal Processing Algorithms on Speech Perception
Official Title
Effects of Nonlinear Signal Processing Algorithms on Speech Perception
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the effect of nonlinear signal processing algorithms on speech perception.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Speech, Hearing Loss, Sensorineural, Hearing Aids
Keywords
speech perception, hearing aids

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Perceptual measures
Arm Type
Experimental
Arm Description
Perception will be measured for different algorithm settings and environmental variables (type of noise and signal-to-noise ratio)
Intervention Type
Device
Intervention Name(s)
Tympan
Intervention Description
Participants will wear a prototype hearing aid (called the Tympan)
Primary Outcome Measure Information:
Title
Speech understanding
Description
Percent words correct will be measured
Time Frame
1-2 hours
Secondary Outcome Measure Information:
Title
Preference
Description
Algorithm preference will be measured for each experimental condition
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Lentz, PhD
Phone
18128558945
Email
jjlentz@iu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Donghyeon Yun
Email
dongyun@iu.edu
Facility Information:
Facility Name
Health Sciences Building
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47408
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Lentz
Phone
812-606-8483
Email
jjlentz@iu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Nonlinear Signal Processing Algorithms on Speech Perception

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