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OpenTrials
Completed

NCT Number: NCT04721327

Remote Care: The Future of Cochlear Implants

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

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Key information

Conditions

Cochlear Implants

Age range

1 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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.

Treatment and study plan

remote CI programming

Other

provision of CI programming provided remotely via Zoom in a 2 hour session

Primary outcomes

  1. electrode impedances

    Time frame: up to 8 months

    measured via CI programming software (kOhm)

  2. electrically evoked compound potential values (neural response telemetry)

    Time frame: up to 8 months

    measured via CI programming software (mV)

  3. datalogging

    Time frame: up to 8 months

    measured via CI programming software (hours per week)

  4. stimulation levels

    Time frame: up to 8 months

    threshold and upper stimulation levels measured via CI programming software (clinical unit)

  5. 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.

  6. 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

  7. 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

Secondary outcomes

  1. Behavior Assessment System for Children, 3rd Edition (BASC-3)

    Time frame: 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.

  2. Patient Health Questionnaire (PHQ-8)

    Time frame: 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).

  3. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 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).

  4. Quality of Life- CI (QoL-CI)

    Time frame: up to 8 months

    QoL-CI is scored 0-100 with higher scores indicating better quality of life.

  5. Cochlear Implant Quality of Life-35 Profile (CIQOL-35 Profile)

    Time frame: 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

  6. Parenting Stress Index/Short Form (PSI)

    Time frame: 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.

  7. Parenting Stress-CI

    Time frame: 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.

  8. Scale of Parental Involvement and Self-Efficacy-Revised (SPISE-R)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Cochlear

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 22, 2021
Registry last updated
Jul 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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