AK-OTOF-NHS-002
Research type
Research Study
Full title
A Natural History Study in Individuals with Otoferlin Gene (OTOF)-Mediated Hearing Loss
IRAS ID
314612
Contact name
Nishchay Mehta
Contact email
Sponsor organisation
Akouos Inc.
Duration of Study in the UK
6 years, 5 months, 1 days
Research summary
This study looks at children born with a particular genetic form of hearing loss – OTOF-mediated.
This type of hearing loss, in some, can progress to almost complete deafness and requires the child to undergo a cochlear implantation operation to provide hearing. This can happen soon after birth and other times after many years.
The rate at which the hearing reduces and factors that help predict this remain unknown.
Our study will look at children historically born with this condition, who consent to participate, and review their hearing and medical history to track how their hearing changed over time. Additionally, those recently identified with this abnormality will be eligible to participate in a forward looking study that will test hearing and health over 60 months.
The sponsor of the trial is Akouos Inc in collaboration with ENT Clinical as the CRO (this is a Julius Clinical entity for ENT studies).
The study will be conducted in several counties USA, Taiwan, Germany, Spain, UK and possibly Australia. It is anticipated that up to 150 participants will be enrolled in total into this study.
Participants may be enrolled into the retrospective study and/or the prospective study.
• For participants that may be enrolled into the retrospective study - Retrospective data collection will begin following consent, eligibility review will occur between screening and Baseline (Month0).No follow up occurs.
• For participants that may be enrolled into the prospective study - following consent, eligibility review will begin followed by 6 monthly study visits up to Month 60.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0249
Date of REC Opinion
17 Oct 2022
REC opinion
Further Information Favourable Opinion