Remote Care: The Future of Cochlear Implants
- Conditions
- Cochlear Implants
- Interventions
- Other: remote CI programming
- Registration Number
- NCT04721327
- Lead Sponsor
- University of Miami
- Brief Summary
The purpose of this study is to see if remote programming visits for cochlear implants are possible.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
-
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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pediatric Arm remote CI programming 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. Adult Arm remote CI programming 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.
- Primary Outcome Measures
Name Time Method electrode impedances up to 8 months measured via CI programming software (kOhm)
auditory skills as measured by the LittleEars Questionnaire 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) 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) 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) up to 8 months measured via CI programming software (mV)
datalogging up to 8 months measured via CI programming software (hours per week)
stimulation levels up to 8 months threshold and upper stimulation levels measured via CI programming software (clinical unit)
- Secondary Outcome Measures
Name Time Method Quality of Life- CI (QoL-CI) up to 8 months QoL-CI is scored 0-100 with higher scores indicating better quality of life.
Parenting Stress Index/Short Form (PSI) 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.
Behavior Assessment System for Children, 3rd Edition (BASC-3) 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.
Generalized Anxiety Disorder-7 (GAD-7) 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).
Scale of Parental Involvement and Self-Efficacy-Revised (SPISE-R) up to 8 months 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.
Parenting Stress-CI up to 8 months 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.
Cochlear Implant Quality of Life-35 Profile (CIQOL-35 Profile) 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
Patient Health Questionnaire (PHQ-8) 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).
Trial Locations
- Locations (1)
University of Miami
🇺🇸Miami, Florida, United States