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Virtual team-based clinic for Hearing Loss

N/A
Waitlist Available
Led By Chrisanda M Sanchez, AuD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial will study whether pediatric cochlear implant patients can have remote visits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year 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 Checklist (ASC) scores
Datalogging
Electrically evoked compound potential values
+3 more
Secondary outcome measures
Behavior Assessment System for Children version 3 (BASC-3) scores
Cochlear Implant Quality of Life-35 Profile (CIQOL-35 Profile) scores
Generalized Anxiety Disorder version 7 (GAD-7) scores
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Pediatric Cochlear Implant Candidate GroupExperimental Treatment1 Intervention
Participants who are in the process of receiving standard of care cochlear implant evaluation. Participants will receive a virtual team-based clinic as a part of the candidacy evaluation process for one year.
Group II: Established Cochlear Implant Recipient GroupExperimental Treatment2 Interventions
Participants who are established cochlear implant recipients. Participants will receive a virtual team-based clinic, including remote cochlear implant programming, for one year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Virtual team-based clinic
2021
N/A
~90
Remote cochlear implant programming
2021
N/A
~90

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
898 Previous Clinical Trials
409,565 Total Patients Enrolled
10 Trials studying Hearing Loss
916 Patients Enrolled for Hearing Loss
Stanley J. Glaser FoundationUNKNOWN
Chrisanda M Sanchez, AuDPrincipal InvestigatorUniversity of Miami

Frequently Asked Questions

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

Is there an upper age limit for those wanting to take part in the trial?

"The terms of eligibility for this medical trial dictate that the minimum age to enroll is 0 and the maximum age is 12."

Answered by AI

What is the scope of participants for this investigation?

"Affirmative, clinicaltrials.gov evidences that this medical trial is actively enlisting patients. It was initially published on the 1st of November 2021 and revised most recently on the 21st of October 2022. 90 individuals are required for recruitment from one location."

Answered by AI

Is the enrollment process still open for this clinical investigation?

"Per clinicaltrials.gov, this medical study is actively searching for participants to enroll in the trial. The experiment was initially posted on November 1st 2021 and had its most recent update on October 21st 2022."

Answered by AI

What key goals are researchers aiming to achieve from this clinical experiment?

"During the one-year clinical trial, our team will be evaluating Upper stimulation levels. Secondary evaluations include Scale of Parental Involvement and Self-Efficacy-Revised (SPISE-R) scores that are rated on a 1 to 7 scale with higher numbers indicating stronger parental involvement and self efficacy; Parenting Stress–CI ratings between 0 and 3 which denote increasing stress levels for parents of children aged 0–5 or 6–12 years old; as well as Behavior Assessment System for Children version 3 (BASC-3) T Scores from 60 to 120 where values above 70 indicate clinically significant areas requiring therapeutic intervention."

Answered by AI

Is it possible for me to participate in this medical research?

"This trial is seeking 90 individuals with auditory impairment aged between 0 and 12. Essential criteria for potential participants include CI candidates who are in the evaluation process, as well as those under 12 years old who have at least 6 months of experience using a remote programming device from an approved company."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~25 spots leftby Apr 2025