Remote Care: The Future of Cochlear Implants

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

Official Title
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Remote Care: The Future of Cochlear Implants

Conditions
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Cochlear Implants

Intervention / Treatment
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* Other: remote CI programming


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pediatric Arm<br>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. | Other: remote CI programming<br>* provision of CI programming provided remotely via Zoom in a 2 hour session<br>|
| Experimental: Adult Arm<br>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. | Other: remote CI programming<br>* provision of CI programming provided remotely via Zoom in a 2 hour session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| electrode impedances | measured via CI programming software (kOhm) | up to 8 months | 
| electrically evoked compound potential values (neural response telemetry) | measured via CI programming software (mV) | up to 8 months | 
| datalogging | measured via CI programming software (hours per week) | up to 8 months | 
| stimulation levels | threshold and upper stimulation levels measured via CI programming software (clinical unit) | up to 8 months | 
| auditory skills as measured by the LittleEars Questionnaire | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemedicine, service delivery model