CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Re-programming of cochlear implantother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03694340
NCT03694340N/ACompleted

Optimization of Cochlear Implant MAP-parameters in Children, Reprogramming Based on Active Co-operation

Göteborg University·interventional·Posted Oct 3, 2018·Updated Dec 4, 2020

In Brief

A clinical study evaluating Re-programming of cochlear implant for Cochlear Implants and 5 related conditions. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 3, 2018
Enrollment StartOct 25, 2018
Primary CompletionJun 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.7 years ago

Interventions

Re-programming of cochlear implantother

New MAP based on behavioral T- and C-levels