An interventional study of Cochlear implant manual insertion and Cochlear implant robotized insertion in Profound Bilateral Hearing Loss, sponsored by Nantes University Hospital. Recruiting at 14 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-31.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate, via a randomised controlled design, the efficacy of the robotic insertion of cochlear implant, versus manual insertion. Robotic insertion will be performed using Robotol.
This is a three years interventional study involving adults with profound bilateral hearing loss.
Eligible subjects will be randomized in two groups : robotic insertion, or manual insertion. Each patient will be followed during 12 months.
Cochlear implants are currently the only option for the rehabilitation of bilateral profound hearing loss. Cochlear implant surgery efficacy has been largely demonstrated by numerous studies. But, despite multiple contributors, accuracy and sensitivity of cochlear implant insertion constitute the major and the single factor that surgeons have under control.
This manual surgery is performed in an extremely constrained environment and must be as much as delicate as possible to preserve patient's residual hearing potential. Manual insertion is still largely subject to experience and dexterity of the surgeon. Factors associated with the surgical insertion (such as incomplete or traumatic insertions, translocations, destruction of residual hearing) have a negative impact on final hearing correction performance.
To optimise the hearing results, the insertion must be precise, linear and atraumatic. These conditions may be achieved by robotic insertion.
The RobOtol® is an innovative robotic assistance system dedicated to ear surgery, designed and built in France. This is a compact serial robot with 7 degrees of freedom and high resolution, allowing lower insertion forces and higher insertion depth than the manual approach. Pilot clinical studies have already reported a reduced frequency of translocations via robotic assistance and a reduction in cochlear trauma.
The objective of Robiicca is to evaluate, via a randomised controlled design, the efficacy at 1 year of this robotic technology in cochlear implantation in adults.The hypothesis is that the optimization of the surgical procedure with the RobOtol® will maximize the audiometric results, as well as the residual hearing and the vestibular function.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's planned enrollment of 550 is above the median of 40 across 764 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
Patients wearing electronic devices directly connected to the brain or nervous system.
Presence of medical conditions that prohibit general anesthesia. Impossibility of viewing the anatomy adequately. Any situation that, in the doctor's opinion, might involve risk for the patient
Manual insertion of the cochlear implant
Procedure: Cochlear implant manual insertion
Robotic insertion of the cochlear implant
Procedure: Cochlear implant robotized insertion
Manual insertion of the cochlear implant into the round window during the surgery
Robotic insertion of the cochlear implant into the round window during the surgery
Speech discrimination score
the speech discrimination score is the percentage of repeated words in silence, with a monosyllabic list, at 60dB, cochlear implant activated.
Time frame: 1 year
Speech discrimination score
Speech discrimination score (percent of words recognized in monosyllabic list) at 60 dB
Time frame: Baseline, 6 months
Speech Reception Threshold (SRT 50)
The speech recognition threshold (SRT) examines at which level 50% of the speech material (usually numbers or spondaic words) is repeated correctly. In addition, SRT gives an index of the hearing sensitivity of speech and helps determine the starting point for other supra-threshold measures such as WR (Word Recognition).
Time frame: 6 months, 12 months
Speech audiometry in noise
Signal to Noise Ratio to achieve 50% or 80% intelligibility (SNR50 and SNR80) with the Fra-Matrix noise test
Time frame: 6 months, 12 months
Rate of incomplete insertion
Number of electrodes inserted at immediate post-operative imaging by Cone Beam or CT scan.
Time frame: Day one post operative
Rate of electrode translocations
Analysis of translocations using software measures after Cone beam or CT scan (blinded centralized analysis)
Time frame: Day one post operative
Residual hearing
Pure Tone Audiometry thresholds, implant deactivated, at 250, 500, 1000, 2000 and 4000 Hz (mean of the 5 frequencies)
Time frame: Baseline, 6 months, 12 months
Pure-tone audiometry
Pure Tone Audiometry thresholds, implant activated, at 250, 500, 1000, 2000 and 4000 Hz (mean of the 5 frequencies)
Time frame: 6 months, 12 months
Complications related to the implant
Complications related to implant surgery (peripheral facial palsy, cerebrospinal fluid leaks, neurovegetative disorders, major bleeding, neurological complications, infections, scars disorders, pain, hematoma, dizziness, tinnitus, tympanic perforations, and implant-linked complications : breakdowns, electrode displacements, magnet displacement, implant body displacement, electrode misplaced)
Time frame: Day one, 1 month, 3 months, 6 months, 12 months
Quality of life of patients with HUI3
HUI-3 classification system consists of 8 attributes including vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain. These attributes range from five or six levels of health states for each attribute.
Time frame: Baseline, one month, 3 months, 6 months, 12 months
Quality of life of patients with EQ-5D
EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys. EQ-5D assesses health status in terms of five dimensions of health and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition.
Time frame: Baseline, one month, 3 months, 6 months, 12 months
Vestibular function with VHIT
Video head impulse test (vHIT) allows to identify the overt and covert saccades and studies the gain of vestibulo-ocular reflex (VOR) of each semicircular canal.
Time frame: Baseline, 12 months
Vestibular function with Caloric test results
The caloric test uses a nonphysiologic stimulus to induce endolymphatic flow in the horizontal semicircular canal and horizontal nystagmus by creating a temperature gradient from one side of the canal to the other.
Time frame: Baseline, 12 months
Vestibular function with MVEP
Myogenic Vestibular Evoked Potential (MVEP) detects the presence of reproductible waveforms of normal morphology in latency and amplitude
Time frame: Baseline, 12 months
Incremental cost-effectiveness ratio (cost per point of speech discrimination score gain) from a collective perspective
Effectiveness criteria will be the speech discrimination score (number of words recognized in monosyllabic list) at 60 dB at M12. Costs will be estimated in 3 steps: 1) direct costs related to treatment (DRG, length of stay) and one month outpatient resources consumption after surgery; 2) monetary valuation of resources consumed (using NHI official tariffs, and data from the French National Hospitals' Cost Study); 3) cost calculation by multiplying quantities of resources with their corresponding units costs.
Time frame: 12 months
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Nantes University Hospital