University of Miami
Miami, Florida, 33136, United States
NCT Number: NCT05030961
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.
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Notify Me0 year–12 year
All sexes
Interventional
Not applicable
Miami, Florida, 33136, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
New patients undergoing CI evaluation:
Established CI recipients:
Exclusion criteria
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 programming will be provided via Zoom on a study-provided encrypted laptop.
Time frame: Up to 1 year
Electrode Impedances values, reported in kOhm, will be extracted from the cochlear implant software
Time frame: Up to 1 year
Electrically evoked compound potential values, reported in mV, will be extracted from the cochlear implant software
Time frame: Up to 1 year
Datalogging, reported in hours per week, will be extracted from the cochlear implant software
Time frame: Up to 1 year
As measured from the cochlear implant software
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.
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
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
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).
Time frame: Up to 1 year
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).
Time frame: Up to 1 year
QoL-CI is scored 0-100 with higher scores indicating better quality of life.
Time frame: Up to 1 year
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
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
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.
University of Miami
Other
Implementation of a Team-based Virtual Clinic for Pediatric Cochlear Implants
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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