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DeafnessELEPHANTNCT03892941

Electric Pace-pitched Hearing Achieves Natural Tonotopy

A study testing Imaged based fitting in people with Deafness, run by Maastricht University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Deafness
What is being tested?
Imaged based fitting
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteNetherlands
Study dates
18 Mar 2019to 18 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Lars Lambriks, Drs. contact

0636166071

lars.lambriks@mumc.nl

Netherlands1 site, 1 recruiting

  • MUMC

    Maastricht, Limburg, 6202 AZ

    Recruiting

Other trials in Netherlands

About this study

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.

Conditions
Deafness
Being tested
Imaged based fitting
Medical subject headings
Deafness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03892941
Study groupRoleWhat they receive
Imaged based fittingExperimentalMapping of the electrical input of the cochlear implant will be based on an individualized natural frequency alignment as estimated with imaging methods.
Receives: Device: Imaged based fitting
Clinical routineNo interventionMapping of the electrical input of the cochlear implant will be based on a one-size-fits-all, as is part of clinical routine.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Speech understanding in quiet with cochlear implant

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

    Measured: During the first 12 months of CI rehabilitation

  2. Speech understanding in quiet with cochlear implant

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

    Measured: During the first 12 months of CI rehabilitation

  3. Speech understanding in noise with cochlear implant

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

    Measured: During the first 12 months of CI rehabilitation

  4. 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).

    Measured: During the first 12 months of CI rehabilitation

Secondary outcomes (10)

  1. Speech understanding with hearing aid

    Speech understanding with hearing aid will be measured with the Dutch Consonant Nucleus Consonant (CNC) test.

    Measured: During the first 12 months of CI rehabilitation

  2. Speech understanding with hearing aid

    Speech understanding with hearing aid will be measured with the Dutch Matrix sentence test.

    Measured: During the first 12 months of CI rehabilitation

  3. Spatial masking

    The Spatial Speech Perception In Noise (SSPIN) test will be used to determine the head shadow and squelch effect [74].

    Measured: During the first 12 months of CI rehabilitation

  4. Listening effort

    In a listening effort test subjects are asked to rate the effort it takes to listen to speech fragments in noise.The listening effort test is based on subjective ratings for the ease or difficulty involved in listening to speech in the presence of varying amounts of noise. Speech and noise are presented from the same loudspeaker in front of the subject. Three relevant signal-to noise ratios will be tested repeatedly (5 times) and the mean effort level will be calculated. Rating is performed using a vertical scale with 13 discrete points (seven named categories interspersed with an empty category) ranging from no effort (Score 0) to extreme effort (Score 12).

    Measured: During the first 12 months of CI rehabilitation

  5. Spectral resolution (SMRT test)

    The ability to spectrally resolve frequency information is known to be related to speech understanding performance (in noise). Frequency selectivity will be monitored to test the ability of the patient to filter out one stimulus from the others on the basis of frequency. This will be done with the Spectral-temporally Modulated Ripple Test (SMRT).

    Measured: During the first 12 months of CI rehabilitation

  6. Loudness scaling (ACALOS test)

    To estimate the course of loudness percept between minimal audible level and maximum comfortable level, a procedure is used that automatically adjusts the presentation levels to the subject's individual auditory dynamic range without employing any pre-measurement. The procedure uses repeated measurements and presents levels in randomized order. It has been named "ACALOS" (Adaptive Categorical LOudness Scaling). Results will provide information about the difference in loudness percept between CI and HA and will give input for optimizing the fitting of these hearing devices across the dynamic range.

    Measured: During the first 12 months of CI rehabilitation

  7. Telemetric data

    By measuring Evoked Compound Action Potential (ECAP), telemetric data on the function of the implant and the response of the auditory nerve will be collected.

    Measured: During the first 12 months of CI rehabilitation

  8. Quality of life in relation to hearing ability.

    Measured with the Speech-Spatial-Qualities (SSQ) questionnaire. A short form of the SSQ (SSQ-12) will be used. The SSQ is designed for use typically as a complement to behavioural or experimental measures of hearing ability and consists of questions on the following domains: speech hearing, spatial hearing, qualities of hearing, and listening effort. Participants will be asked to answer 12 questions on a 10-point Visual Analogue Scale with different units.

    Measured: During the first 12 months of CI rehabilitation

  9. Overall wellbeing

    Measured with the ICEpop CAPability measure for adults (ICECAP-A)

    Measured: During the first 12 months of CI rehabilitation

  10. Overall Quality of life

    Measured with the Health Utility Index Mark 3 (HUI-3)

    Measured: During the first 12 months of CI rehabilitation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2019
  2. Study start18 Mar 2019
  3. Primary completion18 Mar 2021 (estimated)
  4. Study completion18 Mar 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03892941
Sponsor's protocol ID
NL64874.068.18
Acronym
ELEPHANT
Status last verified
Mar 2019
First submitted
20 Mar 2019
Last updated
27 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32576247

Questions about this trial

What is this clinical trial studying?

A study testing Imaged based fitting in people with Deafness, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lars Lambriks, Drs. (0636166071, lars.lambriks@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Speech understanding in quiet with cochlear implant (time frame: During the first 12 months of CI rehabilitation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03892941, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.

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