Clinical trial NCT03892941: Electric Pace-pitched Hearing Achieves Natural Tonotopy
Official title: Electric Pace-pitched Hearing Achieves Natural Tonotopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deafness
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Speech understanding in quiet with cochlear implant
timeFrame: During the first 12 months of CI rehabilitation
measure: Speech understanding in quiet with cochlear implant
timeFrame: During the first 12 months of CI rehabilitation
measure: Speech understanding in noise with cochlear implant
timeFrame: During the first 12 months of CI rehabilitation
measure: Patient preference
timeFrame: During the first 12 months of CI rehabilitation
Secondary outcomes:
measure: Speech understanding with hearing aid
timeFrame: During the first 12 months of CI rehabilitation
measure: Speech understanding with hearing aid
timeFrame: During the first 12 months of CI rehabilitation
measure: Spatial masking
timeFrame: During the first 12 months of CI rehabilitation
measure: Listening effort
timeFrame: During the first 12 months of CI rehabilitation
measure: Spectral resolution (SMRT test)
timeFrame: During the first 12 months of CI rehabilitation
measure: Loudness scaling (ACALOS test)
timeFrame: During the first 12 months of CI rehabilitation
measure: Telemetric data
timeFrame: During the first 12 months of CI rehabilitation
measure: Quality of life in relation to hearing ability.
timeFrame: During the first 12 months of CI rehabilitation
measure: Overall wellbeing
timeFrame: During the first 12 months of CI rehabilitation
measure: Overall Quality of life
timeFrame: During the first 12 months of CI rehabilitation
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: MUMC
state: Limburg
Study officials:
affiliation: Maastricht UMC+
name: Erwin George, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.