NCT03694340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

October 25, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

December 4, 2020

Status Verified

December 1, 2020

Enrollment Period

1.7 years

First QC Date

September 28, 2018

Last Update Submit

December 2, 2020

Conditions

Cochlear ImplantsEvoked Potentials, AuditoryChildDisabilities HearingDeafnessHearing

Outcome Measures

Primary Outcomes (5)

  • Change in speech perception

    Sound field hearing test performed with a pre-recorded speech material consisting of everyday sentences.

    Performed at baseline and 4 months after intervention

  • Change in tone threshold

    Sound field hearing test performed with tones to determine hearing thresholds.

    Performed at baseline and 4 months after intervention

  • Behavioral T-thresholds

    Behavioral measurements of the T-levels that constitutes the the lower level of the dynamic range when programming the cochlear implant (setting the MAP).

    Performed at intervention

  • Behavioral C-thresholds

    Behavioral measurements of the C-levels that constitutes the upper level of the dynamic range when programming the cochlear implant (setting the MAP).

    Performed at intervention

  • Change in automatically recorded electrical evoked action potential thresholds

    The measurement used for programming the cochlear implant if not behavioral measurements are feasible (e.g. small children).

    Performed at baseline and 4 months after intervention

Secondary Outcomes (1)

  • Change in results from "Children's Home Inventory for Listening Difficulties" questionnaire

    Performed at baseline and 4 months after intervention

Study Arms (1)

Re-programming of cochlear implant

OTHER

The cochlear implant is programmed with a new MAP based on behavioral measurements of T- and C-levels and used by the participant for 4 months before follow up.

Other: Re-programming of cochlear implant

Interventions

Re-programming of cochlear implantOTHER

New MAP based on behavioral T- and C-levels

Re-programming of cochlear implant

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Malformation of the cochlea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Göteborgs Universitet, Institute of Neuroscience and Physiology, Section of Rehabilitation and Clinical Neuroscienses

Gothenburg, 40530, Sweden

Location

Related Publications (5)

  • Roland JT Jr, Cosetti M, Wang KH, Immerman S, Waltzman SB. Cochlear implantation in the very young child: Long-term safety and efficacy. Laryngoscope. 2009 Nov;119(11):2205-10. doi: 10.1002/lary.20489.

    PMID: 19507225BACKGROUND

  • de Vos JJ, Biesheuvel JD, Briaire JJ, Boot PS, van Gendt MJ, Dekkers OM, Fiocco M, Frijns JHM. Use of Electrically Evoked Compound Action Potentials for Cochlear Implant Fitting: A Systematic Review. Ear Hear. 2018 May/Jun;39(3):401-411. doi: 10.1097/AUD.0000000000000495.

    PMID: 28945656BACKGROUND

  • Abbas PJ, Brown CJ, Shallop JK, Firszt JB, Hughes ML, Hong SH, Staller SJ. Summary of results using the nucleus CI24M implant to record the electrically evoked compound action potential. Ear Hear. 1999 Feb;20(1):45-59. doi: 10.1097/00003446-199902000-00005.

    PMID: 10037065BACKGROUND

  • Botros A, van Dijk B, Killian M. AutoNR: an automated system that measures ECAP thresholds with the Nucleus Freedom cochlear implant via machine intelligence. Artif Intell Med. 2007 May;40(1):15-28. doi: 10.1016/j.artmed.2006.06.003. Epub 2006 Aug 22.

    PMID: 16920343BACKGROUND

  • Plant K, Law MA, Whitford L, Knight M, Tari S, Leigh J, Pedley K, Nel E. Evaluation of streamlined programming procedures for the Nucleus cochlear implant with the Contour electrode array. Ear Hear. 2005 Dec;26(6):651-68. doi: 10.1097/01.aud.0000188201.86799.01.

    PMID: 16378000BACKGROUND

MeSH Terms

Conditions

Deafness

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lennart Magnusson, PhD

    Sahlgrenska University Hospital, Region Västra Götaland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Single-case research design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2018

First Posted

October 3, 2018

Study Start

October 25, 2018

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

December 4, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)