Hearing LossNCT05030961
Team-based Virtual Pediatric Cochlear Implant Clinic
A study testing Virtual team-based clinic and Remote cochlear implant programming in people with Hearing Loss, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to see if remote visits for pediatric cochlear implant patients are possible. The investigator will be assessing whether a multi-disciplinary team approach can be achieved remotely for patients both undergoing the cochlear implant (CI) process and for those who have already been implanted. Read more about this study
- Who is it for?
- Ages 0 to 12 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Virtual team-based clinic and Remote cochlear implant programming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2021to 1 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 0 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- New patients undergoing CI evaluation:
- English speaking patients (parents can speak English and/or Spanish)
- Ages 0-12 years who are cochlear implant candidates and undergoing the evaluation process
- Established CI recipients:
- English speaking patients (parents can speak English and/or Spanish)
- Ages 1-12 with at least 6 months of CI experience with a company that has remote programming capacity
Who cannot join
- Patients with families who speak languages other than English or Spanish
- 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
Official title: Implementation of a Team-based Virtual Clinic for Pediatric Cochlear Implants
The purpose of this study is to see if remote visits for pediatric cochlear implant patients are possible. The investigator will be assessing whether a multi-disciplinary team approach can be achieved remotely for patients both undergoing the cochlear implant (CI) process and for those who have already been implanted.
- Conditions
- Hearing Loss
- Being tested
- Virtual team-based clinic, Remote cochlear implant programming
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual team-based clinicBehavioural
Virtual team-based clinic will include consultation, counseling, and education from pediatric audiology, psychology, auditory verbal therapy, and education. Each session lasts approximately 30 minutes with a total of 3 sessions within the year.
Remote cochlear implant programmingBehavioural
Remote cochlear implant programming will be provided via Zoom on a study-provided encrypted laptop.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Cochlear Implant Candidate Group | Experimental | Participants who are in the process of receiving standard of care cochlear implant evaluation. Participants will receive a virtual team-based clinic as a part of the candidacy evaluation process for one year. Receives: Behavioral: Virtual team-based clinic |
| Established Cochlear Implant Recipient Group | Experimental | Participants who are established cochlear implant recipients. Participants will receive a virtual team-based clinic, including remote cochlear implant programming, for one year. Receives: Behavioral: Virtual team-based clinic; Behavioral: Remote cochlear implant programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrode Impedances
Electrode Impedances values, reported in kOhm, will be extracted from the cochlear implant software
Measured: Up to 1 year
Electrically evoked compound potential values
Electrically evoked compound potential values, reported in mV, will be extracted from the cochlear implant software
Measured: Up to 1 year
Datalogging
Datalogging, reported in hours per week, will be extracted from the cochlear implant software
Measured: Up to 1 year
Threshold/Upper stimulation levels
As measured from the cochlear implant software
Measured: Up to 1 year
LittleEars questionnaire scores
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 1 year
Auditory Skills Checklist (ASC) scores
ASC has a Total Score ranges from zero to 70, with higher scores indicating development of increasingly complex listening skills
Measured: Up to 1 year
Secondary outcomes (8)
Behavior Assessment System for Children version 3 (BASC-3) scores
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 1 year
Patient Health Questionnaire version 8 (PHQ-8) scores
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 1 year
Generalized Anxiety Disorder version 7 (GAD-7) scores
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 1 year
Quality of Life- CI (QoL-CI) scores
QoL-CI is scored 0-100 with higher scores indicating better quality of life.
Measured: Up to 1 year
Cochlear Implant Quality of Life-35 Profile (CIQOL-35 Profile) scores
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 1 year
Parenting Stress Index/Short Form (PSI) scores
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 1 year
Parenting Stress-CI scores
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 1 year
Scale of Parental Involvement and Self-Efficacy-Revised (SPISE-R) scores
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 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 Nov 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley J. Glaser Foundation
- Responsible party
- Principal investigator, Chrisanda Sanchez, University of Miami
- Investigators
- Chrisanda M Sanchez, AuD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030961
- Sponsor's protocol ID
- 20210584
- Status last verified
- Jun 2023
- First submitted
- 19 Aug 2021
- Last updated
- 2 Jun 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 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Team-based Virtual Clinic for Pediatric Cochlear Implants
- ClinicalTrials.gov ID
- NCT05030961
- Acronym / sponsor ID
- 20210584
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Stanley J. Glaser Foundation
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 1 Sep 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 visits for pediatric cochlear implant patients are possible. The investigator will be assessing whether a multi-disciplinary team approach can be achieved remotely for patients both undergoing the cochlear implant (CI) process and for those who have already been implanted.
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 Cochlear Implant Candidate Group | Experimental | Behavioral: Virtual team-based clinicParticipants who are in the process of receiving standard of care cochlear implant evaluation. Participants will receive a virtual team-based clinic as a part of the candidacy evaluation process for one year. |
| Established Cochlear Implant Recipient Group | Experimental | Behavioral: Virtual team-based clinic, Behavioral: Remote cochlear implant programmingParticipants who are established cochlear implant recipients. Participants will receive a virtual team-based clinic, including remote cochlear implant programming, for one year. |
Who may qualify
- Ages
- 0 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- English speaking patients (parents can speak English and/or Spanish)
- Ages 0-12 years who are cochlear implant candidates and undergoing the evaluation process
- English speaking patients (parents can speak English and/or Spanish)
- Ages 1-12 with at least 6 months of CI experience with a company that has remote programming capacity
Key exclusion criteria (3 listed)
- Patients with families who speak languages other than English or Spanish
- 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 |
|---|---|---|
| Virtual team-based clinicVirtual team-based clinic will include consultation, counseling, and education from pediatric audiology, psychology, auditory verbal therapy, and education. Each session lasts approximately 30 minutes with a total of 3 sessions within the year. | Behavioural | Established Cochlear Implant Recipient Group, Pediatric Cochlear Implant Candidate Group |
| Remote cochlear implant programmingRemote cochlear implant programming will be provided via Zoom on a study-provided encrypted laptop. | Behavioural | Established Cochlear Implant Recipient Group |
Primary outcome
Electrode Impedances
Time frame: Up to 1 year
Electrode Impedances values, reported in kOhm, will be extracted from the cochlear implant software
Electrically evoked compound potential values
Time frame: Up to 1 year
Electrically evoked compound potential values, reported in mV, will be extracted from the cochlear implant software
Datalogging
Time frame: Up to 1 year
Datalogging, reported in hours per week, will be extracted from the cochlear implant software
Threshold/Upper stimulation levels
Time frame: Up to 1 year
As measured from the cochlear implant software
LittleEars questionnaire scores
Time frame: Up to 1 year
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 Checklist (ASC) scores
Time frame: Up to 1 year
ASC has a Total Score ranges from zero to 70, with higher scores indicating development of increasingly complex listening skills
8 secondary outcomes
Behavior Assessment System for Children version 3 (BASC-3) scores
Time frame: Up to 1 year
Patient Health Questionnaire version 8 (PHQ-8) scores
Time frame: Up to 1 year
Generalized Anxiety Disorder version 7 (GAD-7) scores
Time frame: Up to 1 year
Quality of Life- CI (QoL-CI) scores
Time frame: Up to 1 year
Cochlear Implant Quality of Life-35 Profile (CIQOL-35 Profile) scores
Time frame: Up to 1 year
Parenting Stress Index/Short Form (PSI) scores
Time frame: Up to 1 year
Parenting Stress-CI scores
Time frame: Up to 1 year
Scale of Parental Involvement and Self-Efficacy-Revised (SPISE-R) scores
Time frame: Up to 1 year
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 2 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Chrisanda M Sanchez, AuD 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 Virtual team-based clinic and Remote cochlear implant programming in people with Hearing Loss, 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 6 inclusion and 3 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 2 Jun 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 1 year). The study lists 6 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 2 Jun 2023.