Groupe Hospitalier Pitié-Salpêtrière
Paris, 75013, France
Location status: Recruiting
Recruiting
NCT Number: NCT06248398
Impact of Robotic Cochlear Implantation on Hearing Performance in Noise
The purpose of this study is to compare two methods of cochlear implantation : conventional manual insertion versus robot-assisted in order to verify whether robotic insertion provides better performance in the noisy environment.
To do this, we will compare the two methods of insertion of the electrode holder, on 140 patients candidates for cochlear implantation randomized in two groups (70 conventional surgery versus 70 robot-assisted surgery). All patients will be recruited during 17 months, in our Ear, nose and throat (ENT) Department of the Pitié-Salpêtrière hospital group, the first center for adult patients established in France (on average 180 patients/year).
Patient will be followed for 9 months with clinical evaluation, imaging, audiometric, listening effort and quality of life assessments. These evaluations will be carried out preoperatively and postoperatively at 3 months and 6 months post-activation of the cochlear implant.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
In the case of severe (70 to 90dB loss) and profound (>90dB loss) hearing loss, when conventional hearing aids no longer provide sufficient benefit, cochlear implantation remains the only possible solution for hearing rehabilitation. In implanted patients, a clear improvement in communication in silence is observed, but almost all patients have difficulty understanding speech in noisy environments. Cochlear implantation involves inserting an electrode holder into the cochlea during a surgical procedure under general anesthesia. The insertion of the electrode holder must be as minimally traumatic as possible in order to preserve the cochlear structures and avoid post-operative fibrosis that could impact the auditory outcomes.
The conventional method of this surgery is the manual insertion of the electrode holder. In recent years, robotic assistance, the RobOtol®, has been developed with the aim of avoiding the jerks of the surgeon's hand and improving the precision of the insertion. RobOtol® has had its CE marking since 2016 and is used in several hospitals in France and abroad.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Adult patient ≥ 18 years old
- Patients with an indication for uni or bilateral, simultaneous or sequential cochlear implantation: severe to profound bilateral deafness with intelligibility ≤70% for Fournier dissyllabic words, in free field, at 60dB with adapted hearing aids.
- Patient able to understand the information note and give written consent
- Affiliation to a French social security system
Exclusion criteria
- Patient who does not speak French
- Etiologies of deafness known to be of bad prognosis (auditory neuropathy, congenital profound deafness, immediate post-meningitis profound deafness, vestibular schwannoma on the side of the ear to be implanted)
- Impossibility of testing the effect of the cochlear implant alone on hearing results (cochlear implantation in the context of unilateral deafness or fluctuating deafness)
- Cochlear implantation requiring the use of a perimodiolar electrode holder.
- Pregnant and breastfeeding women
- Patients wearing electronic devices, in direct connection with the brain or nervous system
- Patient included in another interventional study (Jardé 1)
- Patient under legal protection (guardianship or curatorship) or deprived of liberty
Treatment and study plan
Surgery with RobOtol®
ProcedurePatient having cochlear implantation surgery with RobOtol®.
Conventional manual surgery
ProcedurePatient having conventional manual cochlear implantation surgery
Primary outcomes
-
Auditory performance in noise with the cochlear implant
Time frame: At 6 months post-implantation
Evolution of the intelligibility score (Variation of the percentage of words understood) for monosyllabic Lafon words presented at 60 dB SPL with a signal-to-noise ratio of 10 dB (SNR10) between the preoperative score and the score at 6 months post-implantation
Secondary outcomes
-
Hearing performance in noise after robotic cochlear implantation compared to conventional manual cochlear implantation for phonemes
Time frame: At 3 and 6 months post-implantation
Evolution of the intelligibility score (Variation of the percentage of words and phonemes understood) for monosyllabic Lafon words presented at 60 dB SPL with a signal-to-noise ratio of 10 dB (SNR10) between the preoperative score and the score at 3 months and at 6 months post-implantation.
-
Hearing performance in noise under ecological conditions after robotic cochlear implantation compared to conventional manual cochlear implantation
Time frame: At 3 and 6 months post-implantation
Evolution of the intelligibility score (Variation of the percentage of words understood) for Fr-Bio words presented at 60 dB SPL with a signal-to-noise ratio of 10 dB (SNR10) between the preoperative score and the score at 3 months and at 6 months post-implantation. The noise will be an ecological noise (restaurant or street noise) using the Immersion® system.
-
Hearing performance in silence after robotic cochlear implantation compared to conventional manual cochlear implantation for words
Time frame: At 3 and 6 months post-implantation
Evolution of the intelligibility score (Variation of the percentage of words understood) for monosyllabic Lafon words presented at 60 dB SPL in quiet between the preoperative score and the score at 3 months and at 6 months post-implantation.
-
Hearing performance in silence after robotic cochlear implantation compared to conventional manual cochlear implantation for phonemes
Time frame: At 3 and 6 months post-implantation
Evolution of the intelligibility score (Variation of the percentage of phonemes understood) for monosyllabic Lafon words presented at 60 dB SPL in quiet between the preoperative score and the score at 3 months and at 6 months post-implantation.
-
The subjective benefit on tinnitus after robotic cochlear implantation compared to conventional manual cochlear implantation
Time frame: At 3 and 6 months post-implantation
Evolution of the Patient's Related Outcomes Measures using questionnaire concerning the tinnitus with the Tinnitus Handicap Inventory (THI)
-
The subjective benefit on quality of life after robotic cochlear implantation compared to conventional manual cochlear implantation
Time frame: At 3 and 6 months post-implantation
Evolution of the Patient's Related Outcomes Measures using the questionnaire concerning the quality of life with the Cochlear Implant Quality of Life (CIQOL)
-
The position of the electrode array in the cochlea during manual and robotic insertions
Time frame: At day one post -implantation
the position of each electrode will be analyzed blindly on the post-operative CT-scan.
-
The impact of a translocation on auditory performance in silence and in noise
Time frame: At 3 and 6 months post-implantation
Auditory scores measured at 3 and 6 months after implantation will be correlated to the presence of a translocation of the electrode array assessed on the post-operative CT scan.
-
The effort of listening in silence and in noise after manual and robotic insertions assessed with the Speech, Spatial and Qualities of Hearing Scale (SSQ)
Time frame: At 3 and 6 months post-implantation
The effort of listening will be analyzed with SSQ scale
-
The effort of listening in silence and in noise after manual and robotic insertions assessed with a visual analog scale
Time frame: At 3 and 6 months post-implantation
The effort of listening will be analyzed after each audiologic test with a visual analog scale, using which the patient will rate from 0 to 10 the effort made to understand the words presented (Bräcker et al., 2019)
-
The preservation of residual hearing after cochlear implantation in cases with residual hearing before surgery
Time frame: At 30 days, 3 months and 6 months post-implantation
Evolution of auditory thresholds measured with tonal audiometry between preoperative and postoperative measurements on the operated ear.
-
The presence of postoperative vertigo in case of robotic cochlear implantation compared to manual implantation
Time frame: At 7 days, 3 months and 6 months post-implantation
Evaluation of vertigo with the Dizziness Handicap Inventory (DHI) questionnaire
Study contacts
Contact information is provided by the study sponsor or research team.
Ghizlene LAHLOU, Dr
CONTACT
Isabelle MOSNIER, Dr
CONTACT
Sponsors and collaborators
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Other
Registry information
Acronym: ROBOT-IC-BRUIT
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Feb 8, 2024
- Registry last updated
- Feb 17, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Completed
Evaluation of a HiRes™ Optima Sound Processing Strategy for the HiResolution™ Bionic Ear
NCT01616576
Severe to Profound Hearing Loss, in Adult Users of Advanced Bionics HiResolution™ Bionic Ear System
Los Angeles, California, United States
View Trial Details