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Recruiting NCT05805384

Evaluating a Noise Reduction Algorithm With Cochlear Implant Users

No phase Interventional Hearing Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SEDA.
Who it may be relevant to
Registry conditions: Hearing Impairment. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Percent of Words Correctly Recognized in Noisy Conditions with SEDA NR [Time frame: Up to Year 2 (Completion of Experiment 1.1)]
  • Percent of Words Correctly Recognized in Noisy Conditions without NR [Time frame: Up to Year 2 (Completion of Experiment 1.1)]
  • Percent of Words Correctly Recognized in Quiet Conditions with SEDA NR [Time frame: Up to Year 2 (Completion of Experiment 1.1)]
  • Percent of Words Correctly Recognized in Quiet Conditions without NR [Time frame: Up to Year 2 (Completion of Experiment 1.1)]
  • Visual Analogue Scale (VAS) Rating of SEDA NR [Time frame: Up to Year 2 (Completion of Experiment 1.2)]
  • Percent of Words Correctly Recognized in Noisy Conditions with Clinical NR [Time frame: Up to Year 2 (Completion of Experiment 2)]
  • Percent of Words Correctly Recognized in Quiet Conditions with Clinical NR [Time frame: Up to Year 2 (Completion of Experiment 2)]
  • Percent of Words Correctly Recognized with no SEDA NR [Time frame: Up to Year 2 (Completion of Experiment 4)]
  • Percent of Words Correctly Recognized with Standard SEDA NR [Time frame: Up to Year 2 (Completion of Experiment 4)]
  • Percent of Words Correctly Recognized with Low-Computation SEDA NR [Time frame: Up to Year 2 (Completion of Experiment 4)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Tisch Hospital — New York

Identifiers

NCT: NCT05805384 · 22-00815 · SB1DC018761

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗