Hearing LossCOSP-1NCT05693610
Open-source Hearing Aid Platform Comparisons
A study testing Portable OSP and Cloud-based OSP in people with Hearing Loss and Hearing Loss, Sensorineural, run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Hearing Loss, Sensorineural
- What is being tested?
- Portable OSP and Cloud-based OSP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2023to 25 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >= 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Outcomes With the Cloud-based and Portable Versions of an Open-source Hearing Aid.
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).
Read the 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.
- Conditions
- Hearing Loss, Hearing Loss, Sensorineural
- Being tested
- Portable OSP, Cloud-based OSP
- Keywords
- Hearing aid, Hearing loss
- Medical subject headings
- Hearing Loss, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable OSPDevice
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 OSPDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Portable OSP | Experimental | Outcomes will be assessed with the portable version of the OSP. Receives: Device: Portable OSP |
| Cloud-based OSP | Experimental | Outcomes will be assessed with the cloud-based version of the OSP. Receives: Device: Cloud-based OSP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-intervention (1 day)
Secondary outcomes (2)
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.
Measured: Post-intervention (1 day)
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.
Measured: Post-intervention (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start6 Jan 2023
- Primary completion25 Apr 2023
- Study completion25 Apr 2023
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Within-subjects design; Different levels of intervention outcomes are compared
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Nadi LLC
- Responsible party
- Principal investigator, Varsha Rallapalli, Northwestern University
- Investigators
- Varsha H Rallapalli, AuD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693610
- Sponsor's protocol ID
- Pro00062688
- Acronym
- COSP-1
- Status last verified
- Nov 2024
- First submitted
- 8 Jun 2022
- Last updated
- 10 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Outcomes With the Cloud-based and Portable Versions of an Open-source Hearing Aid.
- ClinicalTrials.gov ID
- NCT05693610
- Acronym / sponsor ID
- COSP-1 / Pro00062688
- Conditions
- Hearing Loss, Hearing Loss, Sensorineural
- Keywords
- Hearing aid, Hearing loss
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Nadi LLC
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 23 Jan 2023 (actual)
- Results
- Posted 10 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Within-subjects design; Different levels of intervention outcomes are compared
| Arm | Type | Receives |
|---|---|---|
| Portable OSP | Experimental | Device: Portable OSPOutcomes will be assessed with the portable version of the OSP. |
| Cloud-based OSP | Experimental | Device: Cloud-based OSPOutcomes will be assessed with the cloud-based version of the OSP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >= 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portable OSPThe 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. | Device | Portable OSP |
| Cloud-based OSPThe 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. | Device | Cloud-based OSP |
Primary outcome
Word-identification Ability
Time frame: Post-intervention (1 day)
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.
2 secondary outcomes
Phoneme Confusions
Time frame: Post-intervention (1 day)
Response Time
Time frame: Post-intervention (1 day)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Varsha H Rallapalli, AuD, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable OSP and Cloud-based OSP in people with Hearing Loss and Hearing Loss, Sensorineural, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Word-identification Ability (time frame: Post-intervention (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.