Remote Care: The Future of Cochlear Implants

NCT ID: NCT04721327

Last Updated: 2023-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-16

Study Completion Date

2023-06-30

Brief Summary

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The purpose of this study is to see if remote programming visits for cochlear implants are possible.

Detailed Description

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Conditions

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Cochlear Implants

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

remote CI programming

Intervention Type OTHER

provision of CI programming provided remotely via Zoom in a 2 hour session

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.

Group Type EXPERIMENTAL

remote CI programming

Intervention Type OTHER

provision of CI programming provided remotely via Zoom in a 2 hour session

Interventions

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remote CI programming

provision of CI programming provided remotely via Zoom in a 2 hour session

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cochlear

INDUSTRY

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Meredith Holcomb

Associate Professor, Director of Cochlear Implants

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meredith Holcomb

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20201410

Identifier Type: -

Identifier Source: org_study_id

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