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Recruiting NCT07035873

Pediatric Cochlear Implant Remote Programming and Assessment

No phase Interventional Cochlear Implant Listeners

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: Remote Programming, Remote Speech Perception.
Who it may be relevant to
Registry conditions: Cochlear Implant Listeners. Basic parameters: 13 years — 20 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 →

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Overview

This is a prospective, interventional study to evaluate efficacy and end user satisfaction of remote cochlear implant programming in the pediatric population. Additionally, this study will evaluate the long-term replicability of digital audio streaming (DAS) self-assessment speech perception measures via iOS mobile application.

Detailed description

The objectives of this study are to evaluate the efficacy and end user satisfaction of mobile application based (1) remote cochlear implant programming and 2) self-administered audiological test measures in older children (13 to 20 year olds). Based on existing data, we hypothesize that remote programming is efficacious, and provides positive end user satisfaction. Additionally, while our prior work has shown that application-based speech perception outcomes are replicable when measured within one session, repeated testing over time may show learning effects.

Interventions

  • Behavioral Remote Programming
    Use of the Advanced Bionics Target CI remote programming software to complete behavioral measurements of cochlear implant function and programming via telehealth.
  • Diagnostic test Remote Speech Perception
    Use of digital audio streaming (DAS) through a proprietary platform to complete remote speech perception testing of performance with cochlear implants via telehealth.

Primary outcome measures

  • Efficacy and User Satisfaction- Participant [Time frame: From enrollment to end of treatment at 6 months]
  • Efficacy and User Satisfaction- Parent [Time frame: From enrollment to end of treatment at 6 months]
Secondary outcome measures (4)
  • DAS Speech Perception- Single Word Recognition [Time frame: From enrollment to end of treatment at 6 months]
  • DAS Speech Perception- Oldenburg Matrix Task [Time frame: From enrollment to end of treatment at 6 months]
  • DAS Speech Perception- Digits In Noise Task [Time frame: From enrollment to end of treatment at 6 months]
  • DAS Speech Perception- Soft Sound Detection [Time frame: From enrollment to end of treatment at 6 months]

Eligibility criteria

Inclusion criteria

  • Cochlear implantation with an Advanced Bionics cochlear implant in at least one ear.
  • At least 6 months post-implantation listening experience and at least 2 weeks of listening experience with Marvel cochlear implant external processor.
  • Speech perception performance of at least 40% correct on standard of care speech perception measures in quiet for the ear to be used in the study
  • Ages 13 years to 20 years, inclusive
  • Ability and willingness to participate in remote programming sessions and self-administered assessment measures

Exclusion criteria

  • Children under the age of 13
  • Speech perception performance < 40% on SOC speech perception measures
  • Cognitive or language deficits that preclude ability and willingness to participate in remote programming sessions and self-administered assessment measures, as identified by eMR diagnoses and the participant's primary clinical audiologist judgement.

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
  • Nationwide Children's Hospital — Columbus

Identifiers

NCT: NCT07035873 · STUDY00004526

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗