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Study was paused after April 2023 as the decision was made to continue the study with an updated version of test devices. However, the devices are still in production and the site is being closed for the study due to relocation of the PI.
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| Name | Class |
|---|---|
| Nadi LLC | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Portable OSP | Experimental | Outcomes will be assessed with the portable version of the OSP. |
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| Cloud-based OSP | Experimental | Outcomes will be assessed with the cloud-based version of the OSP. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portable OSP | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-intervention (1 day) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-intervention (1 day) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Varsha H Rallapalli, AuD, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Evanston | Illinois | 60208 | United States |
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This was a single arm, within-subjects study design and each participant completed both study interventions. First the portable OSP was tested followed by the cloud-based OSP for all participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Portable OSP, Then Cloud-based OSP | Outcomes will be assessed with the portable and cloud-based versions of the OSP. Portable OSP: 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. Cloud-based OSP: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Portable OSP, Then Cloud-based OSP | Outcomes will be assessed with the portable and cloud-based versions of the OSP. Portable OSP: 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. Cloud-based OSP: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Includes individuals with normal hearing and hearing loss | Posted | Mean | 95% Confidence Interval | percentage of words correct | Post-intervention (1 day) |
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No adverse events to report because all-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Portable OSP | Outcomes will be assessed with the portable version of the OSP. Portable OSP: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Varsha Rallapalli | Northwestern University | 847-467-0897 | varsha8904@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 16, 2024 | Jun 30, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Main Consent Form | Mar 16, 2024 | Jun 30, 2024 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Screener Consent Form | Mar 16, 2024 | Jun 30, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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Within-subjects design; Different levels of intervention outcomes are compared
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Since the portable and cloud-based versions of the device are visibly different, it is not possible to mask the participant.
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| Cloud-based OSP | Device | 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. |
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| 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. | Post-intervention (1 day) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Outcomes will be assessed with the portable version of the OSP.
Portable OSP: 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.
| OG001 | Cloud-based OSP | Outcomes will be assessed with the cloud-based version of the OSP. Cloud-based OSP: 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. |
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| Secondary | 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. | Due to errors in the software, this outcome measure was not collected for any of the participants. | Posted | Post-intervention (1 day) |
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| Secondary | 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. | Includes individuals with normal hearing and hearing loss. | Posted | Mean | 95% Confidence Interval | seconds | Post-intervention (1 day) |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Cloud-based OSP | Outcomes will be assessed with the cloud-based version of the OSP. Cloud-based OSP: 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |