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remote CI programming for Cochlear Implants

N/A
Waitlist Available
Led By Meredith Holcomb
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 months
Awards & highlights

Study Summary

This trial is testing if follow-up appointments for cochlear implants can be done remotely, to see if it's possible.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
auditory skills as measured by the Auditory Skills Checklist (ASC)
auditory skills as measured by the LittleEars Questionnaire
datalogging
+4 more
Secondary outcome measures
Behavior Assessment System for Children, 3rd Edition (BASC-3)
Cochlear Implant Quality of Life-35 Profile (CIQOL-35 Profile)
Generalized Anxiety Disorder-7 (GAD-7)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Pediatric ArmExperimental Treatment1 Intervention
Patient ages 1-17 years who are current cochlear implant (CI) users will receive CI programming in person for the first visit and remotely for the second visit.
Group II: Adult ArmExperimental Treatment1 Intervention
Patient ages 18-90 years who are current cochlear implant (CI) users will receive CI programming in person for the first visit and remotely for the second visit.

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Who is running the clinical trial?

University of MiamiLead Sponsor
902 Previous Clinical Trials
409,986 Total Patients Enrolled
CochlearIndustry Sponsor
89 Previous Clinical Trials
6,001 Total Patients Enrolled
Meredith HolcombPrincipal InvestigatorUniversity of Miami

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aim of this medical trial?

"Cochlear, the trial sponsor, has specified that electrode impedances will be measured as the primary outcome over a 8 month time period. Subsequently, secondary outcomes such as Parenting Stress-CI (a 15/8 item questionnaire with 0 meaning "not at all stressful" and 3 indicating "very stressed"), Behavior Assessment System for Children 3rd Edition (BASC-3) scoring from 0 to 120 where scores between 60 and 70 require monitoring while those above 70 necessitate therapeutic intervention), and Cochlear implant Quality of Life-35 Profile total score ranging from 0 to 100% are also being considered."

Answered by AI

Does this research project have any age restrictions for participants?

"Necessary qualifications for this clinical trial are set between 1 year and 90 years of age. Particularly, 4 individual trials exist that cater to younger individuals, while 14 additional studies focus on patients older than 65 years old."

Answered by AI

Is my eligibility to join this medical trial accepted?

"According to the requirements, individuals with cochlear implants who are between 1 and 90 years old can qualify for this clinical trial. The research team is aiming to enlist 60 participants in total."

Answered by AI

Has enrollment in this investigation been opened up?

"According to the clinicaltrials.gov webpage, this particular trial has ceased recruitment since May 24th 2022 after first being posted on March 16th 2021. Nonetheless, 15 other studies are still recruiting patients at present time."

Answered by AI
~7 spots leftby Apr 2025