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Open-source Hearing Aid Platform Comparisons (COSP-1)

Primary Purpose

Hearing Loss, Hearing Loss, Sensorineural

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Portable OSP
Cloud-based OSP
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring Hearing aid, Hearing loss

Eligibility Criteria

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

Inclusion Criteria: >= 18 years of age; any sex Sensorineural hearing loss with pure-tone thresholds between 25-85 decibel hearing level (dB HL) at octave frequencies between 250 and 3000 Hz Speak English as their primary language Normal or corrected-to-normal vision Participants will be in good health (self-report) Exclusion Criteria: Clinically significant unstable or progressive medical conditions Participants who score < 23 on the cognitive screening test (Montreal Cognitive Assessment) Evidence of conductive hearing loss or middle ear issues Significant history of otologic or neurologic disorders Non English-speaking or non-native English speaking

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Portable OSP

Cloud-based OSP

Arm Description

Outcomes will be assessed with the portable version of the OSP.

Outcomes will be assessed with the cloud-based version of the OSP.

Outcomes

Primary Outcome Measures

Word-identification ability
Word identification ability will be assessed using the Modified Rhyme Test. Participants will select a word out of a choice of six rhyming words. The words may be in quiet or mixed with background noise and will be presented through headphones (for the intervention type: cloud-based OSP) or via loudspeakers (for the intervention type: portable OSP). Participants may be asked to record their responses on paper or via a button/mouse click on a computer or tablet screen. Scores will be based on the percentage of words identified correctly (range: 0-100%). A higher score indicates better word identification ability. The task is expected to take 30 minutes for each test condition.

Secondary Outcome Measures

Phoneme confusions
Phoneme confusions will be obtained from the Modified Rhyme Test conducted in outcome measure 1. The phoneme confusions will be derived by comparing the selected words to the target word in the task and will be presented in terms of number or percentage of substitution, insertion, deletion errors. No addition task is required for this outcome measure.
Response time
Response time will be obtained from the Modified Rhyme Test conducted in outcome measure 1. Response time is a measure of time taken (in seconds) to identify a word correctly or incorrectly.

Full Information

First Posted
June 8, 2022
Last Updated
October 2, 2023
Sponsor
Northwestern University
Collaborators
Nadi, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05693610
Brief Title
Open-source Hearing Aid Platform Comparisons
Acronym
COSP-1
Official Title
Comparing Outcomes With the Cloud-based and Portable Versions of an Open-source Hearing Aid.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 6, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Nadi, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
New discoveries for hearing loss intervention are often impeded by the proprietary nature of commercial hearing aids and their use in scientific research as "black boxes". An open-source speech platform (OSP) was developed to bridge the gap between audiology research and commercial hearing aid features, to promote innovative solutions to meet the needs of the hearing loss community. The OSP can replicate functions found in commercial hearing aids, and provides tools to researchers to access those functions. The purpose of this study is to evaluate portable and cloud-based platforms of the OSP that will enable a wide range of lab and field applications. All human subjects-related activities will be conducted at Northwestern University (single-site study).
Detailed Description
New discoveries for hearing loss intervention are often impeded by the proprietary nature of commercial hearing aids and their use in scientific research as "black boxes". An open-source hearing aid (open-source speech platform or OSP) was developed to bridge the gap between audiology research and the commercialization of hearing aid technologies and to promote innovative solutions to meet the needs of the hearing loss community. The OSP can replicate functions found in commercial hearing aids, and provides tools to researchers and listeners to access those functions. The purpose of this study is to evaluate portable and cloud-based platforms of the OSP that will enable a wide range of lab and field applications by measuring speech perception abilities with the open-source hearing aid in quiet and in noise for adults with and without hearing loss. The study is a within-subjects design that allows for the comparison of outcomes within the same participant. The study will compare performance with two platforms of the open-source hearing aid (portable and cloud-based) for adults with hearing loss and normal hearing. The study will measure performance using tests of word identification. We will test aided performance with clinically validated hearing aid settings in quiet and in noise. Each participant will be presented with all the test conditions, and the order of presentation of the test conditions will be randomized across participants. Statistical analyses will use a repeated measures model to control for correlation between outcomes for the same participant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Hearing Loss, Sensorineural
Keywords
Hearing aid, Hearing loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Within-subjects design; Different levels of intervention outcomes are compared
Masking
None (Open Label)
Masking Description
Since the portable and cloud-based versions of the device are visibly different, it is not possible to mask the participant.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Portable OSP
Arm Type
Experimental
Arm Description
Outcomes will be assessed with the portable version of the OSP.
Arm Title
Cloud-based OSP
Arm Type
Experimental
Arm Description
Outcomes will be assessed with the cloud-based version of the OSP.
Intervention Type
Device
Intervention Name(s)
Portable OSP
Intervention Description
The portable open-source speech processing platform (OSP) is accessed on a browser via a wireless fidelity (WiFi)-enabled portable communication device that carries out all the signal processing. The processed sounds are transmitted to the ears via earpieces known as behind-the-ear receivers in the canal (same as those available with commercial hearing aids). The amount of amplification with the portable OSP will be customized for each listener based on a validated prescription.
Intervention Type
Device
Intervention Name(s)
Cloud-based OSP
Intervention Description
The cloud-based open-source speech processing platform (OSP) is hosted on a web-server which includes the software for all the signal processing. The processed sounds are transmitted to the ears via calibrated headphones. The amount of amplification with the cloud-based OSP will be customized for each listener based on a validated prescription.
Primary Outcome Measure Information:
Title
Word-identification ability
Description
Word identification ability will be assessed using the Modified Rhyme Test. Participants will select a word out of a choice of six rhyming words. The words may be in quiet or mixed with background noise and will be presented through headphones (for the intervention type: cloud-based OSP) or via loudspeakers (for the intervention type: portable OSP). Participants may be asked to record their responses on paper or via a button/mouse click on a computer or tablet screen. Scores will be based on the percentage of words identified correctly (range: 0-100%). A higher score indicates better word identification ability. The task is expected to take 30 minutes for each test condition.
Time Frame
Post-intervention (1 day)
Secondary Outcome Measure Information:
Title
Phoneme confusions
Description
Phoneme confusions will be obtained from the Modified Rhyme Test conducted in outcome measure 1. The phoneme confusions will be derived by comparing the selected words to the target word in the task and will be presented in terms of number or percentage of substitution, insertion, deletion errors. No addition task is required for this outcome measure.
Time Frame
Post-intervention (1 day)
Title
Response time
Description
Response time will be obtained from the Modified Rhyme Test conducted in outcome measure 1. Response time is a measure of time taken (in seconds) to identify a word correctly or incorrectly.
Time Frame
Post-intervention (1 day)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: >= 18 years of age; any sex Sensorineural hearing loss with pure-tone thresholds between 25-85 decibel hearing level (dB HL) at octave frequencies between 250 and 3000 Hz Speak English as their primary language Normal or corrected-to-normal vision Participants will be in good health (self-report) Exclusion Criteria: Clinically significant unstable or progressive medical conditions Participants who score < 23 on the cognitive screening test (Montreal Cognitive Assessment) Evidence of conductive hearing loss or middle ear issues Significant history of otologic or neurologic disorders Non English-speaking or non-native English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Varsha H Rallapalli, AuD, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://thelab.ucsd.edu/osp/
Description
Main website with all the information about open speech platform

Learn more about this trial

Open-source Hearing Aid Platform Comparisons

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