Remote Care: The Future of Cochlear Implants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cochlear Implants
- Sponsor
- University of Miami
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- electrode impedances
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to see if remote programming visits for cochlear implants are possible.
Investigators
Meredith Holcomb
Associate Professor, Director of Cochlear Implants
University of Miami
Eligibility Criteria
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
- •Postlingual patients
- •English speaking patients
- •ages 18-90 years
- •current CI users with a Cochlear Americas device
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.
Outcomes
Primary Outcomes
electrode impedances
Time Frame: up to 8 months
measured via CI programming software (kOhm)
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.
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
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
electrically evoked compound potential values (neural response telemetry)
Time Frame: up to 8 months
measured via CI programming software (mV)
datalogging
Time Frame: up to 8 months
measured via CI programming software (hours per week)
stimulation levels
Time Frame: up to 8 months
threshold and upper stimulation levels measured via CI programming software (clinical unit)
Secondary Outcomes
- Quality of Life- CI (QoL-CI)(up to 8 months)
- Parenting Stress Index/Short Form (PSI)(up to 8 months)
- Behavior Assessment System for Children, 3rd Edition (BASC-3)(up to 8 months)
- Generalized Anxiety Disorder-7 (GAD-7)(up to 8 months)
- Scale of Parental Involvement and Self-Efficacy-Revised (SPISE-R)(up to 8 months)
- Parenting Stress-CI(up to 8 months)
- Cochlear Implant Quality of Life-35 Profile (CIQOL-35 Profile)(up to 8 months)
- Patient Health Questionnaire (PHQ-8)(up to 8 months)