Remote Care: The Future of Cochlear Implants

Cochlear Implants Clinical Trial

Official title:

Remote Care: The Future of Cochlear Implants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04721327
• Other study ID #: 20201410
• Status: Completed
• Phase: N/A
• Start date: March 16, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cochlear Implants

Intervention

Other:
• remote CI programming
provision of CI programming provided remotely via Zoom in a 2 hour session

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Cochlear

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	electrode impedances	measured via CI programming software (kOhm)	up to 8 months
Primary	electrically evoked compound potential values (neural response telemetry)	measured via CI programming software (mV)	up to 8 months
Primary	datalogging	measured via CI programming software (hours per week)	up to 8 months
Primary	stimulation levels	threshold and upper stimulation levels measured via CI programming software (clinical unit)	up to 8 months
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Quality of Life- CI (QoL-CI)	QoL-CI is scored 0-100 with higher scores indicating better quality of life.	up to 8 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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