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NCT03694340

Optimization of Cochlear Implant MAP-parameters in Children

Completed NA Last updated 4 December 2020
What this trial tests

NA trial testing Re-programming of cochlear implant in Cochlear Implants in 15 participants. Completed in 30 June 2020.

Timeline
25 October 2018
Primary endpoint
30 June 2020
30 June 2020

Quick facts

Lead sponsorGöteborg University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposesupportive care
Enrollment15
Start date25 October 2018
Primary completion30 June 2020
Estimated completion30 June 2020
Sites1 location across Sweden

Drugs / interventions tested

Conditions studied

Sponsor

Göteborg University

Who can join

Adults 7 to 14, any sex, with Cochlear Implants or Evoked Potentials, Auditory. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Cochlear Implants

Currently open trials in the same condition.

Other Göteborg University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03694340.

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