Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Location status: Recruiting
NCT Number: NCT07035873
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.
Interested in participating?
Request Info13 year–20 year
All sexes
Interventional
Not applicable
Columbus, Ohio, 43205, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use of the Advanced Bionics Target CI remote programming software to complete behavioral measurements of cochlear implant function and programming via telehealth.
Use of digital audio streaming (DAS) through a proprietary platform to complete remote speech perception testing of performance with cochlear implants via telehealth.
Time frame: From enrollment to end of treatment at 6 months
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 months
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 months
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 months
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 months
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 months
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.
Contact information is provided by the study sponsor or research team.
Nationwide Children's Hospital- Audiology Department
CONTACT
Ursula M Findlen, PhD
CONTACT
Nationwide Children's Hospital
Other
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