NCT03892941

Brief Summary

In search of the best possible outcome for the severe hearing impaired who have regained the ability to hear by means of a cochlear implant (CI), electrical stimulation and the information it carries should match as closely as possible to what the human brain naturally has evolved to cope with and learned to process instead of relying on plasticity to adapt to an induced mismatch. At the moment, however, CI's are fitted with a 'one size fits all' principle. This is known to cause a mismatch between the frequencies presented by the CI electrode array and the frequencies represented at the corresponding natural acoustic location in an individual cochlea. In this study it is hypothesized that an individual imaged based fitting that pursues natural hearing alignment and is implemented from the start of the rehabilitation process, will improve the individual outcomes of electric hearing. The natural fitting strategy is thought to give rise to a steeper learning curve, result in a better performance in challenging listening situations, improve sound quality, complement better with residual acoustic hearing in the contralateral ear and win the preference of CI-recipients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 18, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2021

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

March 20, 2019

Last Update Submit

March 25, 2019

Conditions

Deafness

Outcome Measures

Primary Outcomes (4)

  • Speech understanding in quiet with cochlear implant

    Speech understanding with CI in quiet measured with the Dutch Consonant Nucleus Consonant (CNC) test.

    During the first 12 months of CI rehabilitation

  • Speech understanding in quiet with cochlear implant

    Speech understanding with CI in quiet will be measured with the Dutch Matrix sentence test.

    During the first 12 months of CI rehabilitation

  • Speech understanding in noise with cochlear implant

    Speech understanding with CI in noise will be measured with the Dutch Matrix sentence test.

    During the first 12 months of CI rehabilitation

  • Patient preference

    At every fitting session, patients will be asked to rate their satisfaction with either the control or experimental program on a 10-point Visual Analog Sscale (1 dissatisfied - 10 very satisfied).

    During the first 12 months of CI rehabilitation

Secondary Outcomes (10)

  • Speech understanding with hearing aid

    During the first 12 months of CI rehabilitation

  • Speech understanding with hearing aid

    During the first 12 months of CI rehabilitation

  • Spatial masking

    During the first 12 months of CI rehabilitation

  • Listening effort

    During the first 12 months of CI rehabilitation

  • Spectral resolution (SMRT test)

    During the first 12 months of CI rehabilitation

  • +5 more secondary outcomes

Study Arms (2)

Imaged based fitting

EXPERIMENTAL

Mapping of the electrical input of the cochlear implant will be based on an individualized natural frequency alignment as estimated with imaging methods.

Device: Imaged based fitting

Clinical routine

NO INTERVENTION

Mapping of the electrical input of the cochlear implant will be based on a one-size-fits-all, as is part of clinical routine.

Interventions

Imaged based fittingDEVICE

Mapping of the electrical input of the cochlear implant will be based on an individualized natural frequency alignment as estimated with imaging methods.

Imaged based fitting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (18y or older) and meeting the conventional Dutch CI criteria;
  • Proficient speaker of Dutch language;
  • Post-lingual onset of profound deafness (\> 4 years of age);
  • Subject receives an Advanced Bionics implant with Midscala electrode and an Advanced Bionics sound processor;
  • Prepared to use study specific hearing aid (Phonak) for the duration of the study;
  • Rehabilitation at MUMC+ for the first year after surgery regarding CI as well as HA;
  • Active participation in trial related procedures such as daily randomization and regular testing.

You may not qualify if:

  • Physical or non-physical contraindications for MRI or CT imaging;
  • Additional disabilities that may prevent active participation and testing as per protocol. If there are indications that the mental abilities to comply with the study procedures are insufficient, additional screening will be performed with the Mini-Mental State Examination. Patients will be excluded from the study when the resulting score is lower than 24;
  • Cochlear or neural abnormalities that could affect outcome measures and/or compromise the placement of the electrode as assessed by the CI surgeon;
  • Active participation in another prospective clinical trial;
  • Pregnancy at time of imaging;
  • Requirement for electric-acoustic activation prior to the first year follow-up;
  • Having received a cochlear implant earlier (e.g. explantation or bilateral implantation).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MUMC

Maastricht, Limburg, 6202 AZ, Netherlands

RECRUITING

Related Publications (1)

  • Lambriks LJG, van Hoof M, Debruyne JA, Janssen M, Chalupper J, van der Heijden KA, Hof JR, Hellingman CA, George ELJ, Devocht EMJ. Evaluating hearing performance with cochlear implants within the same patient using daily randomization and imaging-based fitting - The ELEPHANT study. Trials. 2020 Jun 23;21(1):564. doi: 10.1186/s13063-020-04469-x.

    PMID: 32576247DERIVED

MeSH Terms

Conditions

Deafness

Condition Hierarchy (Ancestors)

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

Study Officials

  • Erwin George, Dr.

    Maastricht UMC+

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Lambriks, Drs.

CONTACT

0636166071lars.lambriks@mumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2019

First Posted

March 27, 2019

Study Start

March 18, 2019

Primary Completion

March 18, 2021

Study Completion

March 18, 2021

Last Updated

March 27, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)