Objective Measures 3: test battery refinement and pilot study (OM3)
Research type
Research Study
Full title
Objective Measurements of Cochlear Health Using a Cochlear Implant: Refinement of a Test Battery and a Non-Interventional Pilot Study in Participants who meet UK guidelines for Cochlear Implantation to Inform Future Trials of a Biological Therapy for Hearing Loss
IRAS ID
339481
Contact name
Douglas Hartley
Contact email
Sponsor organisation
Rinri Therapeutics
Duration of Study in the UK
2 years, 1 months, 11 days
Research summary
Cochlear implant (CI) electrodes, when placed inside the cochlea (the organ we hear with), allow us to take measurements directly from the inner ear. This helps healthcare professionals and researchers monitor the health of the cochlea in the inner ear. While some of these measurements are used in clinic, many are only used for research and scientists do not always agree about which of these measurements is best to show efficacy (i.e. if it works)
The first study aim (Stage One) is to address this by choosing a set of measurements to objectively measure cochlear health. We will assess the reliability of three different measures of cochlear health in six experienced CI users. The participants will visit one CI centre five times to take measurements. Collected data will be analysed to decide which of these measures are the most reliable.
The second aim (Stage Two) is to train CI centres how to use these measurements, and to run a pilot for a future clinical trial of Rincell-1. Rincell-1 is a cell therapy that targets hearing loss caused by loss or dysfunction of auditory neurons, which send sounds from the inner ear to the brain. People with age-related hearing loss and Auditory Neuropathy Spectrum Disorder (ANSD) could benefit from Rincell-1, as it has the potential to replace these auditory neurons and improve hearing in affected individuals.
No participants will receive Rincell-1 in the pilot but will undergo the same tests as the future trial, identifying any potential challenges in setup and recruitment. After CI surgery, participants will be followed up for 13 months, including at-home daily measurements and 6 clinic visits.
A patient survey will also be run to collect feedback from people with hearing loss to confirm the future Rincell-1 trial it is designed to best fit their needs.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
24/EM/0089
Date of REC Opinion
5 Jun 2024
REC opinion
Further Information Favourable Opinion