Clinical trial NCT06235073: Robotic and Manual Cochlear Implantation: An Intra-individual Study of Speech Recognition and Electrode Holder Position (ICRobMan)
Official title: Robotic and Manual Cochlear Implantation: An Intra-individual Study of Speech Recognition and Electrode Holder Position
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cochlear Hearing Loss
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 10
Sex: ALL
Minimum age (years): 44
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective intra-individual study involved 10 patients who underwent bilateral cochlear implantation at a tertiary referral center. Manual cochlear implantations were performed between January 2006 and June 2020, while robot-assisted implantations took place between September 2020 and May 2022. Sequential implantation was applied to 9 of the patients, while 1 patient underwent both manual and robot-assisted cochlear implantations in a single procedure.

Brief summary: Cochlear implantation (CI) allows rehabilitation for patients with severe to profound hearing impairment. Although the use of a robotic assistant provides technical assistance to the surgeon, the assessment of the impact of its use on auditory outcomes remains uncertain, due to inter-individual variability of preoperative audiometric thresholds and the various possible intrascalar positions of the electrode array. WThe investigators aim to compare the hearing results of patients who underwent bilateral cochlear implantation, one side was performed with manual insertion and the other side with robot-assisted insertion. The electrode array intrascalar positioning and the surgery duration were also studied.

This retrospective intra-individual study involved 10 patients who underwent bilateral cochlear implantation. The unique composition of this cohort enabled the investigators to utilize each patient as their own control.

Detailed description: Cochlear implantation (CI) allows rehabilitation for patients with severe to profound hearing impairment. Although the use of a robotic assistant provides technical assistance to the surgeon, the assessment of the impact of its use on auditory outcomes remains uncertain, due to inter-individual variability of preoperative audiometric thresholds and the various possible intrascalar positions of the electrode array. The investigators aim to compare the hearing results of patients who underwent bilateral cochlear implantation, one side was performed with manual insertion and the other side with robot-assisted insertion. The electrode array intrascalar positioning and the surgery duration were also studied.

This retrospective intra-individual study involved 10 patients who underwent bilateral cochlear implantation. The unique composition of this cohort enabled the investigators to utilize each patient as their own control.

Eligibility criteria: Inclusion Criteria:

* bilateral cochlear implantation at a tertiary referral center
* one side manual
* one side robot-assisted

Exclusion Criteria:

* opposition
* under curatorship

Primary outcomes:
measure: Speech disyllabic recognition
timeFrame: at 1 year
Secondary outcomes:
measure: Pure tone average
timeFrame: At 1 year
measure: Intrascalar positionning
timeFrame: Postoperatively
Other outcomes:
Locations:
city: Brest
country: France
facility: Chru de Brest
Study officials:
References: