Optimization of Cochlear Implant MAP-parameters in Children
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|ClinicalTrials.gov Identifier: NCT03694340|
Recruitment Status : Enrolling by invitation
First Posted : October 3, 2018
Last Update Posted : November 12, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cochlear Implants Evoked Potentials, Auditory Child Disabilities Hearing Deafness Hearing||Other: Re-programming of cochlear implant||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single-case research design|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Optimization of Cochlear Implant MAP-parameters in Children, Reprogramming Based on Active Co-operation|
|Actual Study Start Date :||October 25, 2018|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Re-programming of cochlear implant
The cochlear implant is programmed with a new MAP based on behavioral measurements of T- and C-levels and used by the participant for 3 months before follow up.
Other: Re-programming of cochlear implant
New MAP based on behavioral T- and C-levels
- Change in speech perception [ Time Frame: Performed at baseline and 3 months after intervention ]Sound field hearing test performed with a pre-recorded speech material consisting of everyday sentences.
- Change in tone threshold [ Time Frame: Performed at baseline and 3 months after intervention ]Sound field hearing test performed with tones to determine hearing thresholds.
- Behavioral T-thresholds [ Time Frame: Performed at intervention ]Behavioral measurements of the T-levels that constitutes the the lower level of the dynamic range when programming the cochlear implant (setting the MAP).
- Behavioral C-thresholds [ Time Frame: Performed at intervention ]Behavioral measurements of the C-levels that constitutes the upper level of the dynamic range when programming the cochlear implant (setting the MAP).
- Change in automatically recorded electrical evoked action potential thresholds [ Time Frame: Performed at baseline and 3 months after intervention ]The measurement used for programming the cochlear implant if not behavioral measurements are feasible (e.g. small children).
- Change in results from "Children's Home Inventory for Listening Difficulties" questionnaire [ Time Frame: Performed at baseline and 3 months after intervention ]The questionnaire "Children's Home Inventory for Listening Difficulties" assesses the subjective effect on the child's hearing of the re-programming of the cochlear implant. The questionnaire refers both the participant (the child) and the caregiver separately, and consists of 15 questions of different everyday hearing situation. Each question is answered on a rating scale of 1 - 8; a higher grading indicates better hearing (i.e. better outcome). The result is presented as a mean of all the ratings for the participant and the caregiver, respectively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694340
|Göteborgs Universitet, Institute of Neuroscience and Physiology, Section of Rehabilitation and Clinical Neuroscienses|
|Gothenburg, Sweden, 40530|
|Principal Investigator:||Lennart Magnusson, PhD||Sahlgrenska University Hospital, Region Västra Götaland|