Clinical trial NCT04721327: Remote Care: The Future of Cochlear Implants
Official title: Remote Care: The Future of Cochlear Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cochlear Implants
Keywords: telemedicine
service delivery model
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Cochlear
First posted: 2021-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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


Eligibility criteria: 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.

Primary outcomes:
measure: electrode impedances
timeFrame: up to 8 months
measure: electrically evoked compound potential values (neural response telemetry)
timeFrame: up to 8 months
measure: datalogging
timeFrame: up to 8 months
measure: stimulation levels
timeFrame: up to 8 months
measure: auditory skills as measured by the LittleEars Questionnaire
timeFrame: up to 8 months
measure: auditory skills as measured by the Auditory Skills Checklist (ASC)
timeFrame: up to 8 months
measure: hearing disability as measured by the Speech, Spatial and Qualities Hearing Scale (SSQ)
timeFrame: up to 8 months
Secondary outcomes:
measure: Behavior Assessment System for Children, 3rd Edition (BASC-3)
timeFrame: up to 8 months
measure: Patient Health Questionnaire (PHQ-8)
timeFrame: up to 8 months
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: up to 8 months
measure: Quality of Life- CI (QoL-CI)
timeFrame: up to 8 months
measure: Cochlear Implant Quality of Life-35 Profile (CIQOL-35 Profile)
timeFrame: up to 8 months
measure: Parenting Stress Index/Short Form (PSI)
timeFrame: up to 8 months
measure: Parenting Stress-CI
timeFrame: up to 8 months
measure: Scale of Parental Involvement and Self-Efficacy-Revised (SPISE-R)
timeFrame: up to 8 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Meredith Holcomb
role: PRINCIPAL_INVESTIGATOR
References: