- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04721327
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
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
-
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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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
- English speaking patients (Parents can speak English and/or Spanish)
- ages 1-17 years
- current CI users with a Cochlear Americas device
- minimum of 6-months of CI experience
- maximum of 4 years of CI experience
Adult Arm
- Postlingual patients
- 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:
- Patients with physical neuropathy, abnormal anatomy (e.g., cochlear malformations), severe cognitive deficits, and/or severe mental health difficulties
- Patients who do not speak English
- Patients who do not have access to the internet
- Patients who do not live in Florida
- 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.
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provision of CI programming provided remotely via Zoom in a 2 hour session
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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
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measured via CI programming software (kOhm)
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up to 8 months
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electrically evoked compound potential values (neural response telemetry)
Time Frame: up to 8 months
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measured via CI programming software (mV)
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up to 8 months
|
datalogging
Time Frame: up to 8 months
|
measured via CI programming software (hours per week)
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up to 8 months
|
stimulation levels
Time Frame: up to 8 months
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threshold and upper stimulation levels measured via CI programming software (clinical unit)
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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
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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.
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up to 8 months
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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).
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up to 8 months
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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).
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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.
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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
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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
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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.
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up to 8 months
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Scale of Parental Involvement and Self-Efficacy-Revised (SPISE-R)
Time Frame: up to 8 months
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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.
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up to 8 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Keywords
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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