Cochlear ImplantsNCT04721327
Remote Care: The Future of Cochlear Implants
A study testing remote CI programming in people with Cochlear Implants, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to see if remote programming visits for cochlear implants are possible. Read more about this study
- Who is it for?
- Ages 1 year to 90 years
- Conditions the study is for
- Cochlear Implants
- What is being tested?
- remote CI programming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to see if remote programming visits for cochlear implants are possible.
- Conditions
- Cochlear Implants
- Being tested
- remote CI programming
- Keywords
- telemedicine, service delivery model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote CI programmingOther
provision of CI programming provided remotely via Zoom in a 2 hour session
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Arm | Experimental | 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. Receives: Other: remote CI programming |
| Adult Arm | Experimental | 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. Receives: Other: remote CI programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
electrode impedances
measured via CI programming software (kOhm)
Measured: up to 8 months
electrically evoked compound potential values (neural response telemetry)
measured via CI programming software (mV)
Measured: up to 8 months
datalogging
measured via CI programming software (hours per week)
Measured: up to 8 months
stimulation levels
threshold and upper stimulation levels measured via CI programming software (clinical unit)
Measured: 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.
Measured: 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
Measured: 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
Measured: up to 8 months
Secondary outcomes (8)
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.
Measured: 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).
Measured: 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).
Measured: up to 8 months
Quality of Life- CI (QoL-CI)
QoL-CI is scored 0-100 with higher scores indicating better quality of life.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start16 Mar 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Cochlear
- Responsible party
- Principal investigator, Meredith Holcomb, University of Miami
- Investigators
- Meredith Holcomb, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721327
- Sponsor's protocol ID
- 20201410
- Status last verified
- Jul 2023
- First submitted
- 19 Jan 2021
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Care: The Future of Cochlear Implants
- ClinicalTrials.gov ID
- NCT04721327
- Acronym / sponsor ID
- 20201410
- Conditions
- Cochlear Implants
- Keywords
- telemedicine, service delivery model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Cochlear
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if remote programming visits for cochlear implants are possible.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric Arm | Experimental | Other: remote CI programmingPatient 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 | Experimental | Other: remote CI programmingPatient 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. |
Who may qualify
- Ages
- 1 year to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remote CI programmingprovision of CI programming provided remotely via Zoom in a 2 hour session | Other | Adult Arm, Pediatric Arm |
Primary outcome
electrode impedances
Time frame: up to 8 months
measured via CI programming software (kOhm)
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)
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
8 secondary outcomes
Behavior Assessment System for Children, 3rd Edition (BASC-3)
Time frame: up to 8 months
Patient Health Questionnaire (PHQ-8)
Time frame: up to 8 months
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: up to 8 months
Quality of Life- CI (QoL-CI)
Time frame: up to 8 months
Cochlear Implant Quality of Life-35 Profile (CIQOL-35 Profile)
Time frame: up to 8 months
Parenting Stress Index/Short Form (PSI)
Time frame: up to 8 months
Parenting Stress-CI
Time frame: up to 8 months
Scale of Parental Involvement and Self-Efficacy-Revised (SPISE-R)
Time frame: up to 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Cochlear Implants
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Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
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An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
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Active, not recruiting
An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App
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Pitch Perception and Memory: Deficits and Training
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meredith Holcomb principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remote CI programming in people with Cochlear Implants, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
electrode impedances (time frame: up to 8 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.