Evaluating a Noise Reduction Algorithm With Cochlear Implant Users

NCT ID: NCT05805384

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2027-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this study, a noise reduction algorithm will be implemented in various listening situations to evaluate its effectiveness in improving speech understanding for cochlear implant users ages 12 and older.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hearing Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cochlear Implant Users

Participants will complete up to 4 experiments evaluating the use of the Speech Enhancement using Dynamic thresholding Approach (SEDA) algorithm. Each testing session will take between 4-6 hours to complete. Testing sessions will continue until the completion of the experiments.

Group Type EXPERIMENTAL

SEDA

Intervention Type DEVICE

Speech Enhancement using Dynamic thresholding Approach (SEDA) is a software algorithm that removes background noise.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SEDA

Speech Enhancement using Dynamic thresholding Approach (SEDA) is a software algorithm that removes background noise.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* At least 12 years of age.
* Be post-lingually deafened cochlear implant recipients with at least 6 months experience regardless of manufacturer.
* The PI must also deem the child to be developmentally able to complete the experiments.

Exclusion Criteria

• Anyone who is not a cochlear implant user or is aged under 12 years.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David M. Landsberger

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tisch Hospital

New York, New York, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

David M. Landsberger

Role: CONTACT

Phone: 212-263-8455

Email: [email protected]

Natalia Stupak

Role: CONTACT

Phone: 646-501-4153

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SB1DC018761

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-00815

Identifier Type: -

Identifier Source: org_study_id