Electric Pace-pitched Hearing Achieves Natural Tonotopy (ELEPHANT)

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.

Study Overview

• Status: Unknown
• Conditions: Deafness
• Intervention / Treatment: Device: Imaged based fitting

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lars Lambriks, Drs.; Phone Number: 0636166071; Email: lars.lambriks@mumc.nl

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6202 AZ
      • Recruiting
      • MUMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imaged based fitting; 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; Mapping of the electrical input of the cochlear implant will be based on an individualized natural frequency alignment as estimated with imaging methods.
No Intervention: Clinical routine; Mapping 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech understanding with hearing aid	Speech understanding with hearing aid will be measured with the Dutch Consonant Nucleus Consonant (CNC) test.	During the first 12 months of CI rehabilitation
Speech understanding with hearing aid	Speech understanding with hearing aid will be measured with the Dutch Matrix sentence test.	During the first 12 months of CI rehabilitation
Spatial masking	The Spatial Speech Perception In Noise (SSPIN) test will be used to determine the head shadow and squelch effect [74].	During the first 12 months of CI rehabilitation
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).	During the first 12 months of CI rehabilitation
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).	During the first 12 months of CI rehabilitation
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.	During the first 12 months of CI rehabilitation
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.	During the first 12 months of CI rehabilitation
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.	During the first 12 months of CI rehabilitation
Overall wellbeing	Measured with the ICEpop CAPability measure for adults (ICECAP-A)	During the first 12 months of CI rehabilitation
Overall Quality of life	Measured with the Health Utility Index Mark 3 (HUI-3)	During the first 12 months of CI rehabilitation

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Investigators: Principal Investigator: Erwin George, Dr., Maastricht UMC+

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2019
• Primary Completion (Anticipated): March 18, 2021
• Study Completion (Anticipated): March 18, 2021

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 27, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: NL64874.068.18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No