Skip to content

Perilymph Analysis in Cochlear Implant Recipients

Perilymph Analysis in Cochlear Implant Recipients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12626000913370
Enrollment
52
Registered
2026-07-24
Start date
2024-04-15
Completion date
2028-09-22
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We aim to recruit 157 cochlear implant recipients into this observational cohort study. At the time of surgery a small sample of cochlear fluid called perilymph will be collected as well as testing of electrical impedances and the cochlear response (ECochG). Perilymph samples will undergo sequencing of the non-coding RNA fraction (transcriptomes). Participants will be given the option to provide a blood sample for whole exome sequencing. The analysis will be combined with electrophysiological data derived from the implant in the 3 months following surgery as well as clinical outcomes of interest. We expect that expression analysis (miRNA) will correlate with genetic and electrophysiological data. We anticipate that these precision diagnostics will act as predictors of clinical outcomes.

Interventions

The study recruits participants who are eligible to receive a cochlear implant, typically with severe or profound sensorineural hearing loss in at least one ear. During cochlear implant surgery, a small amount (2-5 micro-liters) of perilymph (fluid within the cochlea) will be sampled for the purposes of micro-RNA (miRNA) analysis. Participants will be given the option to have their sample undergo whole exome sequencing. Participants will also undergo Electrocochleography during surgery and at

The study recruits participants who are eligible to receive a cochlear implant, typically with severe or profound sensorineural hearing loss in at least one ear. During cochlear implant surgery, a small amount (2-5 micro-liters) of perilymph (fluid within the cochlea) will be sampled for the purposes of micro-RNA (miRNA) analysis. Participants will be given the option to have their sample undergo whole exome sequencing. Participants will also undergo Electrocochleography during surgery and at surgical follow-up 1 day, 1 month and 3 months post-op. Electrocochleography (ECochG) is an objective test that measures the electrical potentials generated by the inner ear (cochlea) in response to sound. This testing is done to observe the function of the cochlear sensory cells during insertion of the cochlear implant electrode and during recovery after surgery. Participants will also have hearing tests (pure-tone audiometry and speech testing) at follow up visits.

Sponsors

University of Melbourne
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Healthy volunteers
No

Inclusion criteria

All adult and paediatric cochlear implant recipients

Exclusion criteria

- Unwilling to comply with study requirements ie. attendance at post-op reviews.

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 10, 2026