Hearing LossEarly Phase 1NCT04777669
Removing Background Talker Noise for Cochlear Implant Users
A Early Phase 1 study testing Noise Reduction in people with Hearing Loss, run by York Sound Inc at 1 site in United States.
Trial summary
When hearing-impaired listeners are properly aided with a hearing aid (HA) or cochlear implant (CI), they are often able to comfortably maintain a conversation in quiet environments. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Noise Reduction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2020to 31 Mar 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects with CIs 12 years of age and older with no diagnosis of other communicative or cognitive disorders. Subjects must have native or native-like English proficiency.
Who cannot join
- No diagnosed cognitive or communicative disorders (other than hearing loss), presence of acute/chronic otitis media, useable acoustic hearing, and non-English speaking.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
New York University School of Medicine
New York, New York, 10016
Natalia Stupak, AuD, 646-501-4153, Natalia.Stupak@nyulangone.org
About this study
When hearing-impaired listeners are properly aided with a hearing aid (HA) or cochlear implant (CI), they are often able to comfortably maintain a conversation in quiet environments. However, in group environments, such as a large family dinner, restaurant, or other environment where multiple people are talking simultaneously, hearing-impaired listeners have great difficulty participating in conversations and frequently withdraw or avoid the situation. As such, it would be highly beneficial to implement an algorithm into HAs or CIs to remove background talkers ("babble") from the signal to reduce listening effort for the hearing-impaired listener and allow them to converse as if they were in a quiet environment. Although HAs and CIs frequently incorporate noise reduction algorithms, these algorithms are not effective when the background is babble. The problem of removing babble involves segregating speech from speech. Hence, the spectral properties of the signal and noise are extremely similar.
Despite these challenges, we developed an algorithm to remove background babble. In the following study will test the ability of cochlear implant users to understand speech with background babble noise using our noise reduction algorithm or no noise reduction algorithm. We hypothesize that CI users will be able to understand significantly more speech in babble noise when using our algorithm.
- Conditions
- Hearing Loss
- Being tested
- Noise Reduction
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noise ReductionOther
In within subject design, listeners will have background noise removed by a noise reduction algorithm
| Study group | Role | What they receive |
|---|---|---|
| Experiment | Experimental | Subjects will be tested for their ability to understand speech with and without noise reduction Receives: Other: Noise Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Recognition
The % of words correctly understood in various noisy situations will be measured
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start25 Apr 2020
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- York Sound Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NYU Langone Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777669
- Sponsor's protocol ID
- SBIR01
- Status last verified
- Jul 2022
- First submitted
- 25 Feb 2021
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data requests will be considered on a case by case basis
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Removing Background Talker Noise for Cochlear Implant Users
- ClinicalTrials.gov ID
- NCT04777669
- Acronym / sponsor ID
- SBIR01
- Conditions
- Hearing Loss
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- York Sound IncIndustry (pharma, biotech, devices)
- Collaborators
- NYU Langone Health
- Study start
- 25 Apr 2020 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When hearing-impaired listeners are properly aided with a hearing aid (HA) or cochlear implant (CI), they are often able to comfortably maintain a conversation in quiet environments. However, in group environments, such as a large family dinner, restaurant, or other environment where multiple people are talking simultaneously, hearing-impaired listeners have great difficulty participating in conversations and frequently withdraw or avoid the situation. As such, it would be highly beneficial to implement an algorithm into HAs or CIs to remove background talkers ("babble") from the signal to reduce listening effort for the hearing-impaired listener and allow them to converse as if they were in a quiet environment. Although HAs and CIs frequently incorporate noise reduction algorithms, these algorithms are not effective when the background is babble. The problem of removing babble involves segregating speech from speech. Hence, the spectral properties of the signal and noise are extremely similar.
Despite these challenges, we developed an algorithm to remove background babble. In the following study will test the ability of cochlear implant users to understand speech with background babble noise using our noise reduction algorithm or no noise reduction algorithm. We hypothesize that CI users will be able to understand significantly more speech in babble noise when using our algorithm.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experiment | Experimental | Other: Noise ReductionSubjects will be tested for their ability to understand speech with and without noise reduction |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with CIs 12 years of age and older with no diagnosis of other communicative or cognitive disorders. Subjects must have native or native-like English proficiency.
Key exclusion criteria (1 listed)
- No diagnosed cognitive or communicative disorders (other than hearing loss), presence of acute/chronic otitis media, useable acoustic hearing, and non-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 |
|---|---|---|
| Noise ReductionIn within subject design, listeners will have background noise removed by a noise reduction algorithm | Other | Experiment |
Primary outcome
Speech Recognition
Time frame: 1 day
The % of words correctly understood in various noisy situations will be measured
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Individual participant dataSharing planned: No. Data requests will be considered on a case by case basis
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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.
New York University School of Medicine
New York, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Noise Reduction in people with Hearing Loss, run by York Sound Inc 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Jul 2022. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech Recognition (time frame: 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 12 Jul 2022.