Robotic and Manual Cochlear Implantation: An Intra-individual Study of Speech Recognition and Electrode Holder Position (ICRobMan)

Completed

• Conditions: Cochlear Hearing Loss

• Registration Number: NCT06235073
• Lead Sponsor: University Hospital, Brest

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.

Study Timeline

• Study Start: 2023-07-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2023-10
• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2024-01-23
• Last Update Submitted: 2024-01-23
• Study First Posted: 2024-01-31
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

• opposition
• under curatorship

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Speech disyllabic recognition	at 1 year

Secondary Outcome Measures

Name	Time	Method
Intrascalar positionning	Postoperatively
Pure tone average	At 1 year

Trial Locations

Locations (1)

Chru de Brest; 🇫🇷 Brest, France