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Optimization of Cochlear Implant MAP-parameters in Children

NCT03694340 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-12-04

No results posted yet for this study

Summary

This project will complete a long-term follow up for children that have received cochlear implants (CI) early in life and had their CI's programmed based on objective measurements.

At Sahlgrenska University Hospital in Gothenburg, generally, all younger children (0-3 years), the last ten years, had their CI's programmed based on objective measurements. The programming of the CI carried out during the first year after the surgical insertion is done on the foundation of the objective measurements and is generally what the child will live with thereafter. This method also seem to be close to other clinics in Sweden and the rest of the world, however, there are no specific guidelines regarding the how the programming of the CI is to be carried out on small children. To this date there are no studies, to our knowledge, that have confirmed the validity of using these objective measurements and if it is the best for the child. We therefore aim to do a long term follow up on children that have received CI and programmed this way, and study if there would be beneficial to redo the programming when the child is old enough to actively participate.

The aim with this project is evaluate how suitable it is to mainly use objective measurements when programming the cochlear implant and, in addition to this, examine if the children's hearing can be improved if the programming is based on the behavioral measurements of sound when the children are old enough to participate in such. It will examine what happens with the end result if the programming foundation differentiates from one another; if there are any measurable differences in hearing skills.

The result from this project expects to generate knowledge that is highly important for those working with small children receiving CI's, and by extension it will benefit the children that rely on this device in there every day life.

Conditions

  • Cochlear Implants
  • Evoked Potentials, Auditory
  • Child
  • Disabilities Hearing
  • Deafness
  • Hearing

Interventions

OTHER

Re-programming of cochlear implant

New MAP based on behavioral T- and C-levels

Sponsors & Collaborators

  • Vastra Gotaland Region

    collaborator OTHER_GOV

  • Göteborg University

    lead OTHER

Principal Investigators

  • Lennart Magnusson, PhD · Sahlgrenska University Hospital, Region Västra Götaland

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-25
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03694340 on ClinicalTrials.gov