Clinical trial NCT06424262: Performance and Hearing-related Outcomes in Adults Implanted With the CI622D Dexamethasone-eluting Cochlear Implant Compared to Those Implanted With a Standard Cochlear Implant (CI622)
Official title: A Pivotal, Prospective, Multi-centre, Randomised Controlled, 6-month Blinded Investigation Followed by a 6-month Open-label Phase Evaluating the Efficacy of a Dexamethasone Eluting Slim Straight Electrode (CI622D) in the Reduction of Impedance as Compared to a Standard Slim Straight Electrode (CI622) in a Newly Implanted Adult Population With Post-linguistic, Bilateral, Moderately Severe to Profound Sensorineural Hearing Loss.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hearing Loss, Bilateral Sensorineural
Hearing Loss, Sensorineural
Hearing Loss, Bilateral
Hearing Loss, Cochlear
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: QbD Clinical
name: Avania
First posted: 2024-05-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical study will test a newly developed cochlear implant known as CI622D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone. Dexamethasone works to ease inflammation, which is common after any surgical procedure. The goal is to learn if there are added benefits in implant performance and hearing outcomes with the dexamethasone-releasing cochlear implant (CI622D) vs. the standard cochlear implant (CI622) without dexamethasone. The study will be conducted in adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve. The study participants will undergo a series of tests that include testing their implant and their hearing. They will also complete questionnaires to see how they rate their hearing ability and their overall general health.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older (at time of consent)
* Clinically established post-linguistic bilateral moderately severe to profound sensorineural hearing loss
* Meets local candidacy criteria for cochlear implantation
* Compromised functional hearing with a hearing aid in the ear to be implanted
* Willing to participate in and comply with all requirements of the protocol, including willingness to be randomised to either arm
* Evidence of pneumococcal vaccination (e.g., Pneumovax) according to local guidelines prior to randomisation
* Candidate is proficient in the language used to assess speech perception performance
* Willing and able to provide written informed consent.

Exclusion Criteria:

* Planned for a partial insertion of the electrode array
* Intra-axial (within the brain) lesions or deafness due to lesions of the acoustic nerve affecting the ear to be implanted
* Middle ear infection (including acute otitis media, chronic otitis media, suppurative otitis media, or serous drainage) in the ear to be implanted either at the time of surgery or within 3 months prior to enrolment
* Active autoimmune disease or active immunosuppressive therapy
* Any of the following in the ear to be implanted within 3 months prior to enrolment: history of prior otologic surgery including grommets, or tympanic membrane perforation
* Previously reported diagnosis of auditory neuropathy, in the ear to be implanted
* Previously reported diagnosis, in the ear to be implanted, of Large Vestibular Aqueduct Syndrome (LVAS), Meniere's disease, or cochlear hydrops
* Ossification, otosclerosis, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by imaging, in the ear to be implanted
* Current cerebrospinal fluid (CSF) shunts or drains, existing perilymph fistula, temporo- parietal skull fracture or CSF leaks
* History of bacterial meningitis
* Known allergic reaction or contraindication to dexamethasone or corticosteroids
* Severe, or poorer, bilateral sensorineural hearing loss prior to 5 years of age, as reported by the subject
* Severe, or poorer, sensorineural hearing loss of more than 20 years, as reported by the subject, in the ear to be implanted
* Prior cochlear implantation, in either ear
* Medical plan for cochlear implantation during the clinical investigation, contralateral to the ear to be implanted
* Medical or psychological conditions that contraindicate general anaesthesia, surgery or participation in the clinical investigation, as determined by the investigator
* Women who are pregnant
* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the Investigator
* Additional disabilities that may affect the subject's participation or safety during the clinical investigation, as determined by the Investigator
* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as spouse, parent, child, or sibling to the study candidate
* Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation
* Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by investigator or Sponsor to not impact this investigation)
* Subjects recruited at a French site who are not affiliated with social security
* Subjects recruited at a French site who are under legal protection.

Primary outcomes:
measure: Difference in the mean monopolar 1+2 (MP1+2) impedance between CI622D (Investigational Medical Device) and CI622 (control device) at 6 months post-activation
timeFrame: 6 months post-activation
Secondary outcomes:
measure: Difference in mean (within-subject) change in word recognition score in the preferred unilateral listening mode in quiet from pre-implantation to post-activation with CI622D compared with CI622
timeFrame: Pre-implantation, 3, 6, 12 months post-activation
measure: Proportion of participants who experience an adverse event and the proportion of participants who experience a device deficiency with CI622D and CI622
timeFrame: Throughout study (12 months)
measure: Difference in the mean unaided acoustic hearing thresholds pre-operatively, and from activation to post-activation between CI622D and CI622
timeFrame: Pre-operative, 0, 3, 6, 12 months post-activation
measure: Mean within-subject change in word recognition score in the preferred unilateral listening mode in quiet from pre-implantation to post-activation with CI622D
timeFrame: Pre-implantation, 3, 6, 12 months post-activation
measure: Mean change (within-subject) in word recognition score in the preferred bilateral listening mode in quiet from pre-implantation to post-activation with CI622D
timeFrame: Pre-implantation, 3, 6, 12 months post-activation
measure: Difference in mean (within-subject) change in word recognition score in the preferred bilateral listening mode in quiet from pre-implantation to post-activation with CI622D compared with CI622
timeFrame: Pre-implantation, 3, 6, 12 months post-activation
measure: Difference in mean (within-subject) change in sentence recognition score in noise in the preferred unilateral listening mode from pre-implantation to post-implantation with CI622D compared with CI622
timeFrame: Pre-implantation, 3, 6, 12 months post-activation
measure: Difference in mean (within-subject) change in sentence recognition score in noise in the preferred bilateral listening mode from pre-implantation to post-implantation with CI622D compared with CI622
timeFrame: Pre-implantation, 3, 6, 12 months post-activation
measure: Difference in the mean nested bipolar impedances and MP1+2 impedances between CI622D and CI622 measured intraoperatively and from activation to post-activation
timeFrame: Intraoperative, at activation and 3, 6 and 12 months post-activation.
measure: Difference in the mean estimated sound processor battery life for CI622D compared from activation to post-activation with CI622
timeFrame: 0, 3, 6,12 months post-activation
measure: Difference in mean within-subject changes in global score on the Speech, Spatial, and Qualities of Hearing Scale (SSQ12) from pre-implantation to post-activation between CI622D and CI622
timeFrame: Pre-implantation, 3, 6, 12 months post-activation
measure: Difference in mean within-subject changes in global Health Utilities Index III (HUI3) from pre-implantation to post-activation between CI622D and CI622
timeFrame: Pre-implantation, 3, 6, 12 months post-activation
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Macquarie University
state: New South Wales
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Westmead Private Hospital
state: New South Wales
city: Melbourne E.
country: Australia
facility: Royal Victorian Eye and Ear Hospital
state: Victoria
city: Melbourne
country: Australia
facility: St Vincent Private Hospital
state: Victoria
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
city: Paris
country: France
facility: Hôpital Universitaire Pitié-Salpêtrière
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire Toulouse
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
state: Freiburg im Breisgau
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Southampton
country: United Kingdom
facility: University of Southampton
Study officials:
affiliation: Universitätsklinikum Freiburg
name: Antje Aschendorff
role: PRINCIPAL_INVESTIGATOR
References: