NCT04721327

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 16, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

2.3 years

First QC Date

January 19, 2021

Last Update Submit

July 11, 2023

Conditions

Cochlear Implants

Keywords

telemedicineservice delivery model

Outcome Measures

Primary Outcomes (7)

  • electrode impedances

    measured via CI programming software (kOhm)

    up to 8 months

  • electrically evoked compound potential values (neural response telemetry)

    measured via CI programming software (mV)

    up to 8 months

  • datalogging

    measured via CI programming software (hours per week)

    up to 8 months

  • stimulation levels

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

    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.

    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

    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

    up to 8 months

Secondary Outcomes (8)

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

    up to 8 months

  • Patient Health Questionnaire (PHQ-8)

    up to 8 months

  • Generalized Anxiety Disorder-7 (GAD-7)

    up to 8 months

  • Quality of Life- CI (QoL-CI)

    up to 8 months

  • Cochlear Implant Quality of Life-35 Profile (CIQOL-35 Profile)

    up to 8 months

  • +3 more secondary outcomes

Study Arms (2)

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.

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.

Other: remote CI programming

Interventions

remote CI programmingOTHER

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

Adult ArmPediatric Arm

Eligibility Criteria

Age1 Year - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Study Officials

  • Meredith Holcomb

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Director of Cochlear Implants

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 22, 2021

Study Start

March 16, 2021

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

July 13, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)