Remote Care: The Future of Cochlear Implants

July 11, 2023 updated by: Meredith Holcomb, University of Miami
The purpose of this study is to see if remote programming visits for cochlear implants are possible.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Pediatric Arm

  1. English speaking patients (Parents can speak English and/or Spanish)
  2. ages 1-17 years
  3. current CI users with a Cochlear Americas device
  4. minimum of 6-months of CI experience
  5. maximum of 4 years of CI experience

Adult Arm

  1. Postlingual patients
  2. English speaking patients

2. ages 18-90 years 3. current CI users with a Cochlear Americas device 4. minimum of 3-months of CI experience 5. maximum of 18-months of CI experience

Exclusion Criteria:

  1. Patients with physical neuropathy, abnormal anatomy (e.g., cochlear malformations), severe cognitive deficits, and/or severe mental health difficulties
  2. Patients who do not speak English
  3. Patients who do not have access to the internet
  4. Patients who do not live in Florida
  5. Patients who have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pediatric Arm
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.
provision of CI programming provided remotely via Zoom in a 2 hour session
Experimental: Adult Arm
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.
provision of CI programming provided remotely via Zoom in a 2 hour session

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
electrode impedances
Time Frame: up to 8 months
measured via CI programming software (kOhm)
up to 8 months
electrically evoked compound potential values (neural response telemetry)
Time Frame: up to 8 months
measured via CI programming software (mV)
up to 8 months
datalogging
Time Frame: up to 8 months
measured via CI programming software (hours per week)
up to 8 months
stimulation levels
Time Frame: up to 8 months
threshold and upper stimulation levels measured via CI programming software (clinical unit)
up to 8 months
auditory skills as measured by the LittleEars Questionnaire
Time Frame: up to 8 months
The LittleEars auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance.
up to 8 months
auditory skills as measured by the Auditory Skills Checklist (ASC)
Time Frame: up to 8 months
ASC has a Total Score ranges from zero to 70, with higher scores indicating development of increasingly complex listening skills
up to 8 months
hearing disability as measured by the Speech, Spatial and Qualities Hearing Scale (SSQ)
Time Frame: up to 8 months
The SSQ is a a 49 item self-report test of hearing disability across three main sections and 10 pragmatic subscales. The total score ranges from zero to ten, with a lower score indicating a higher degree of hearing disability
up to 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavior Assessment System for Children, 3rd Edition (BASC-3)
Time Frame: up to 8 months
BASC-3 is scored 0-120 as a T score. Any scores between 60-70 is considered at risk / requires monitoring and scores greater than 70 are considered clinically significant / an area that likely requires therapeutic intervention.
up to 8 months
Patient Health Questionnaire (PHQ-8)
Time Frame: up to 8 months
PHQ-8 has 8 items rated on a scale from "not at all" (0) to "nearly every day" (3), with higher scores indicating greater frequency of depressive symptoms. The sum of the items indicates the overall level of depressive symptoms indicating mild (5-9), moderate (10-14), moderately severe (15-19), and severe depressive symptoms (20- 24).
up to 8 months
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: up to 8 months
GAD-7 is a 7-item self-report questionnaire of anxiety symptomatology in the past 14 days. Respondents rate the frequency of each item during the past two weeks on a 0-3-point scale ranging from not at all (0) to nearly every day (3). The sum of the items indicates the overall level of anxiety symptoms indicating mild (0-4), moderate (5-9), moderately severe (10-14), and severe (15- 21).
up to 8 months
Quality of Life- CI (QoL-CI)
Time Frame: up to 8 months
QoL-CI is scored 0-100 with higher scores indicating better quality of life.
up to 8 months
Cochlear Implant Quality of Life-35 Profile (CIQOL-35 Profile)
Time Frame: up to 8 months
CIQOL-35 Profile is a 35 item questionnaire with a total score ranging from 0-100% with a higher score indicating a higher level of functional ability with a cochlear implant
up to 8 months
Parenting Stress Index/Short Form (PSI)
Time Frame: up to 8 months
Parenting Stress Index/Short Form (PSI) contains 36 items rated on a 6-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree) and a total score. Higher scores indicate increased parenting stress.
up to 8 months
Parenting Stress-CI
Time Frame: up to 8 months
Parenting Stress-CI is completed by the parent and scored from "not at all stressful" (0) to "very stressful" (3) with higher scores indicating greater degrees of parenting stress. For parents of children 0-5 years, there are 15 items. For parents of children 6-12 years there are 8 items.
up to 8 months
Scale of Parental Involvement and Self-Efficacy-Revised (SPISE-R)
Time Frame: up to 8 months
The SPISE-R is comprised of 46 questions that uses a 7-point Likert scale to query parents' beliefs, knowledge, confidence, and actions relevant to supporting their child's auditory access and spoken language development. The total average score will range from 1 to 7 with 7 indicating the highest score / highest level of parental involvement and self efficacy.
up to 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Meredith Holcomb, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2021

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 19, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 20201410

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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