search
Back to results

Electric Pace-pitched Hearing Achieves Natural Tonotopy (ELEPHANT)

Primary Purpose

Deafness

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Imaged based fitting
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deafness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Sites / Locations

  • MUMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Imaged based fitting

Clinical routine

Arm Description

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

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

Outcomes

Primary Outcome Measures

Speech understanding in quiet with cochlear implant
Speech understanding with CI in quiet measured with the Dutch Consonant Nucleus Consonant (CNC) test.
Speech understanding in quiet with cochlear implant
Speech understanding with CI in quiet will be measured with the Dutch Matrix sentence test.
Speech understanding in noise with cochlear implant
Speech understanding with CI in noise will be measured with the Dutch Matrix sentence test.
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).

Secondary Outcome Measures

Speech understanding with hearing aid
Speech understanding with hearing aid will be measured with the Dutch Consonant Nucleus Consonant (CNC) test.
Speech understanding with hearing aid
Speech understanding with hearing aid will be measured with the Dutch Matrix sentence test.
Spatial masking
The Spatial Speech Perception In Noise (SSPIN) test will be used to determine the head shadow and squelch effect [74].
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).
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).
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.
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.
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.
Overall wellbeing
Measured with the ICEpop CAPability measure for adults (ICECAP-A)
Overall Quality of life
Measured with the Health Utility Index Mark 3 (HUI-3)

Full Information

First Posted
March 20, 2019
Last Updated
March 25, 2019
Sponsor
Maastricht University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03892941
Brief Title
Electric Pace-pitched Hearing Achieves Natural Tonotopy
Acronym
ELEPHANT
Official Title
Electric Pace-pitched Hearing Achieves Natural Tonotopy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
March 18, 2021 (Anticipated)
Study Completion Date
March 18, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imaged based fitting
Arm Type
Experimental
Arm Description
Mapping of the electrical input of the cochlear implant will be based on an individualized natural frequency alignment as estimated with imaging methods.
Arm Title
Clinical routine
Arm Type
No Intervention
Arm Description
Mapping of the electrical input of the cochlear implant will be based on a one-size-fits-all, as is part of clinical routine.
Intervention Type
Device
Intervention Name(s)
Imaged based fitting
Intervention Description
Mapping of the electrical input of the cochlear implant will be based on an individualized natural frequency alignment as estimated with imaging methods.
Primary Outcome Measure Information:
Title
Speech understanding in quiet with cochlear implant
Description
Speech understanding with CI in quiet measured with the Dutch Consonant Nucleus Consonant (CNC) test.
Time Frame
During the first 12 months of CI rehabilitation
Title
Speech understanding in quiet with cochlear implant
Description
Speech understanding with CI in quiet will be measured with the Dutch Matrix sentence test.
Time Frame
During the first 12 months of CI rehabilitation
Title
Speech understanding in noise with cochlear implant
Description
Speech understanding with CI in noise will be measured with the Dutch Matrix sentence test.
Time Frame
During the first 12 months of CI rehabilitation
Title
Patient preference
Description
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).
Time Frame
During the first 12 months of CI rehabilitation
Secondary Outcome Measure Information:
Title
Speech understanding with hearing aid
Description
Speech understanding with hearing aid will be measured with the Dutch Consonant Nucleus Consonant (CNC) test.
Time Frame
During the first 12 months of CI rehabilitation
Title
Speech understanding with hearing aid
Description
Speech understanding with hearing aid will be measured with the Dutch Matrix sentence test.
Time Frame
During the first 12 months of CI rehabilitation
Title
Spatial masking
Description
The Spatial Speech Perception In Noise (SSPIN) test will be used to determine the head shadow and squelch effect [74].
Time Frame
During the first 12 months of CI rehabilitation
Title
Listening effort
Description
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).
Time Frame
During the first 12 months of CI rehabilitation
Title
Spectral resolution (SMRT test)
Description
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).
Time Frame
During the first 12 months of CI rehabilitation
Title
Loudness scaling (ACALOS test)
Description
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.
Time Frame
During the first 12 months of CI rehabilitation
Title
Telemetric data
Description
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.
Time Frame
During the first 12 months of CI rehabilitation
Title
Quality of life in relation to hearing ability.
Description
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.
Time Frame
During the first 12 months of CI rehabilitation
Title
Overall wellbeing
Description
Measured with the ICEpop CAPability measure for adults (ICECAP-A)
Time Frame
During the first 12 months of CI rehabilitation
Title
Overall Quality of life
Description
Measured with the Health Utility Index Mark 3 (HUI-3)
Time Frame
During the first 12 months of CI rehabilitation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lars Lambriks, Drs.
Phone
0636166071
Email
lars.lambriks@mumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erwin George, Dr.
Organizational Affiliation
Maastricht UMC+
Official's Role
Principal Investigator
Facility Information:
Facility Name
MUMC
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202 AZ
Country
Netherlands
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32576247
Citation
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.
Results Reference
derived

Learn more about this trial

Electric Pace-pitched Hearing Achieves Natural Tonotopy

We'll reach out to this number within 24 hrs