Pediatric Cochlear Implant Remote Programming and Assessment
ConditionCochlear Implant Listeners
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-20
SponsorNationwide Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Remote Programming
BehavioralUse of the Advanced Bionics Target CI remote programming software to complete behavioral measurements of cochlear implant function and programming via telehealth.
Remote Speech Perception
Diagnostic testUse of digital audio streaming (DAS) through a proprietary platform to complete remote speech perception testing of performance with cochlear implants via telehealth.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Remote Programming & AssessmentExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Efficacy and User Satisfaction- Participant
End user satisfaction as measured by survey of remote cochlear implant programming in the pediatric population. A variety of questions will be asked with Likert scale ratings, Scale = 1 (strongly disagree) to 5 (strongly agree), multiple choice, or open-ended questions.
Time frame
From enrollment to end of treatment at 6 months2
Efficacy and User Satisfaction- Parent
End user satisfaction as measured by survey of remote cochlear implant programming in the pediatric population. A variety of questions will be asked with Likert scale ratings, Scale = 1 (strongly disagree) to 5 (strongly agree), multiple choice, or open-ended questions.
Time frame
From enrollment to end of treatment at 6 monthsSecondary outcomes
1
DAS Speech Perception- Single Word Recognition
Speech perception performance measured via digital audio streaming (DAS) task via iOS application. Single word recognition is measured by typing the word heard and measured in percent correct.
Time frame
From enrollment to end of treatment at 6 months2
DAS Speech Perception- Oldenburg Matrix Task
Speech perception performance measured via digital audio streaming (DAS) task via iOS application. The Oldenburg Matrix Task is a closed-set sentence in noise task in which the listener selects the five words heard in the sentence presented. Performance is measured in percent correct, speech recognition threshold (in dB), and signal-to-noise ratio slope.
Time frame
From enrollment to end of treatment at 6 months3
DAS Speech Perception- Digits In Noise Task
Speech perception performance measured via digital audio streaming (DAS) task via iOS application. The Digits in Noise Task is a closed-set word in noise task in which the listener selects the three digits (numbers) heard. Performance is measured in percent correct and speech recognition threshold (in dB).
Time frame
From enrollment to end of treatment at 6 months4
DAS Speech Perception- Soft Sound Detection
Speech perception performance measured via digital audio streaming (DAS) task via iOS application. The soft sound detection task is a threshold seeking tasks where the listener adjusts the level of a warble tone presented in noise until they deem it to be just barely noticeable. Performance is measured in dB level for frequencies 250, 500, 1000, 2000, 3000, 4000, and 6000 Hz.
Time frame
From enrollment to end of treatment at 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nationwide Children's Hospital
Lead sponsor
Advanced Bionics
Collaborator
Source ClinicalTrials.gov