Status Telemetry for Cochlear Implantations

Sensorineural Hearing Loss Clinical Trial

— PATHOS  

Official title:

Prospective Study of Status Telemetry for Cochlear Implantations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06223724
• Other study ID #: PATHOS
• Status: Recruiting
• Start date: October 25, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: January 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Stephan Schraivogel, MSc
• Phone: +41 31 632 76 15
• Email: stephan.schraivogel[@]unibe.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cochlear implants (CIs) are well-established neuroprosthesis used to restore hearing for patients with partial or complete deafness. However, the audiological outcomes of these implants can vary widely, and one reason for this is suboptimal electrode placement. The gold standard for measuring electrode positions is computed tomography (CT) scans, but they are expensive and expose patients to additional radiation, which is especially harmful for children. This study investigates an alternative approach using impedance telemetry data to estimate electrode positions without exposing patients to radiation. For this purpose, an extended telemetry version of a CE-certified cochlear implant software is used. The advanced impedance telemetry software can measure impedance subcomponents with improved measurement resolution that could be used for more accurate estimation of electrode insertion depth using specially designed estimation software. Ultimately, the investigators want to demonstrate the potential to improve audiological outcomes of cochlear implant recipients without exposing them to additional radiation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed Consent signed by the subject
• Subjects scheduled for CI surgery according to clinical routine
• Subjects who will receive a cochlear implant of the MED-EL portfolio (FLEX series arrays)
• No radiological contraindications
• Stated willingness to comply with all study procedures for the duration of the study

Exclusion Criteria:

• Lack of compliance with any inclusion criteria
• Subjects incapable of giving informed consent
• Age under 18 years
• Pregnancy

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss

Intervention

Device:
• STOP
Software to measure impedance telemetry data
• MAESTRO
Software to measure impedance telemetry data

Locations

Country	Name	City	State
Switzerland	Inselspital, Bern University Hospital Department of ENT, Head and Neck Surgery	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linear error of electrode insertion depth estimation	Linear error (in mm) in impedance-based estimation of cochlear implant electrode insertion depth compared to ground truth from CT scans.	At the first post-operative CT scan according to conventional clinical routine (+0-4weeks)
Primary	Linear error of electrode insertion depth estimation	Linear error (in mm) in impedance-based estimation of cochlear implant electrode insertion depth compared to ground truth from CT scans.	At the additional post-operative CT scan (+3 months)
Secondary	Intra-operative progression of impedance subcomponents	Intra-operative measurement of access resistance and polarization impedance measured by the STOP software at several positions of the electrode array in the cochlea (stepwise insertion). The results will be expressed in kOhm (kO).	During cochlear implantation (day 0)
Secondary	Post-operative progression of electrode insertion depth estimation	Post-operative cochlear implant electrode insertion depth estimation using a phenomenological model based on access resistance and polarization impedance measured by the STOP software after full insertion of the electrode array. The results will be expressed in kOhm (kO).	Recordings will be made during cochlear implant surgery (day 0) and at three follow-up visits (+2weeks, +4weeks, +12weeks).
Secondary	Angular error of electrode insertion depth estimation	Angular error (in degrees) in impedance-based estimation of cochlear implant electrode insertion depth using a phenomenological model compared to ground truth from CT scans.	At the first post-operative CT scan according to conventional clinical routine (+0-4weeks)
Secondary	Angular error of electrode insertion depth estimation	Angular error (in degrees) in impedance-based estimation of cochlear implant electrode insertion depth using a phenomenological model compared to ground truth from CT scans.	At the additional post-operative CT scan (+3 months)