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Application of Ideal Binary Masking to Disordered Speech

Primary Purpose

Hearing Loss, Sensorineural, Dysarthria

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Ideal binary mask

About this trial

This is an interventional basic science trial for Hearing Loss, Sensorineural

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:INCLUSION CRITERIA for All Participants

Native speakers of American English
No history of speech or language impairment
No significant prior contact with persons having neurogenic speech disorders

INCLUSION CRITERIA for Participants with Normal Hearing

18 to 70 years of age
Auditory thresholds of 20 dB HL or better bilaterally at octave frequencies from 250-8000 Hz (if under 55 years of age)
Auditory thresholds of 25 dB HL or better bilaterally at octave frequencies from 250-4000 Hz (if over 55 years of age)

INCLUSION CRITERIA for Participants with Sensorineural Hearing Loss

18 to 70 years of age

Exclusion Criteria:

EXCLUSION CRITERIA for All Participants
Mild or profound hearing loss
Conductive or mixed hearing loss
Asymmetric hearing loss
Obvious concomitant cognitive or mental impairment
Unable to achieve upward of 20% words correct

Sites / Locations

Utah State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Normal Hearing

Hearing Impaired

Arm Description

Listeners with normal hearing

Listeners with hearing loss

Outcomes

Primary Outcome Measures

Percent correct speech intelligibility

Percent of keywords correctly identified by the participant for the unprocessed and processed speech stimuli

Secondary Outcome Measures

Full Information

NCT ID

NCT05244603

First Posted

February 4, 2022

Last Updated

February 14, 2022

Sponsor

Utah State University

1. Study Identification

Unique Protocol Identification Number

NCT05244603

Brief Title

Application of Ideal Binary Masking to Disordered Speech

Official Title

Application of Ideal Binary Masking to Disordered Speech

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2021 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Utah State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Dysarthria and hearing loss are communication disorders that can substantially reduce intelligibility of speech and the addition of background noise adds a further challenge. This proposal utilizes an established signal processing technique, currently exploited for improved understanding of speech in noise for listeners with hearing loss, to investigate its potential application to overcome speech-in-noise difficulties for listeners understanding dysarthric speech. Successful completion of this project will demonstrate proof-of-concept for the application of this signal processing technique to dysarthric speech in noise, and inform the development of an R01 proposal to perform a large-scale evaluation of the technology, and clinically meaningful implications, in a broad range of disordered speech types and severities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hearing Loss, Sensorineural, Dysarthria

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Normal Hearing

Arm Type

Experimental

Arm Description

Listeners with normal hearing

Arm Title

Hearing Impaired

Arm Type

Experimental

Arm Description

Listeners with hearing loss

Intervention Type

Behavioral

Intervention Name(s)

Ideal binary mask

Intervention Description

Speech in noise processed by ideal binary mask to reduce background noise

Primary Outcome Measure Information:

Title

Percent correct speech intelligibility

Description

Percent of keywords correctly identified by the participant for the unprocessed and processed speech stimuli

Time Frame

One hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria:INCLUSION CRITERIA for All Participants Native speakers of American English No history of speech or language impairment No significant prior contact with persons having neurogenic speech disorders INCLUSION CRITERIA for Participants with Normal Hearing 18 to 70 years of age Auditory thresholds of 20 dB HL or better bilaterally at octave frequencies from 250-8000 Hz (if under 55 years of age) Auditory thresholds of 25 dB HL or better bilaterally at octave frequencies from 250-4000 Hz (if over 55 years of age) INCLUSION CRITERIA for Participants with Sensorineural Hearing Loss 18 to 70 years of age Exclusion Criteria: EXCLUSION CRITERIA for All Participants Mild or profound hearing loss Conductive or mixed hearing loss Asymmetric hearing loss Obvious concomitant cognitive or mental impairment Unable to achieve upward of 20% words correct

Facility Information:

Facility Name

Utah State University

City

Logan

State/Province

Utah

ZIP/Postal Code

43221

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sarah Leopold, PhD

Phone

614-570-8258

sarah.leopold@usu.edu

First Name & Middle Initial & Last Name & Degree

Stephanie Borrie, PhD

stephanie.borrie@usu.edu

12. IPD Sharing Statement

Plan to Share IPD

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Application of Ideal Binary Masking to Disordered Speech

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