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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
Sponsor:
Collaborator:
Vastra Gotaland Region
Information provided by (Responsible Party):
Göteborg University

Brief 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.


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

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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).


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Cochlear implant by Cochlear Ltd type: CI24RE or newer
  • Received cochlear implant before three years of age
  • Have carried out hearing tests with tones and speech recognition

Exclusion Criteria:

  • Malformation of the cochlea

Information from the National Library of Medicine

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


Locations
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Sweden
Göteborgs Universitet, Institute of Neuroscience and Physiology, Section of Rehabilitation and Clinical Neuroscienses
Gothenburg, Sweden, 40530
Sponsors and Collaborators
Göteborg University
Vastra Gotaland Region
Investigators
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Principal Investigator: Lennart Magnusson, PhD Sahlgrenska University Hospital, Region Västra Götaland

Publications:
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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03694340     History of Changes
Other Study ID Numbers: VGRFOU-247791
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms