the type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise
the different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use
A prospective cross-sectional study analysing the utility of novel tablet-based audiometry and an interactive web-based hearing app as screening tools for drug-induced ototoxicity in adults with cystic fibrosis.
Adults with CF regularly receive anti-infective therapy that can result in impaired hearing. Recent studies have identified that up to 50% of adults with CF have hearing loss with resulting significant impact on quality of life. At present, however, there is no national recommendation to screen for hearing loss within adult CF.
Formal hearing tests are costly, require specialist staff and equipment and require further outpatient visits resulting in significant impact on health, social and financial resource. A novel interactive Apple-iPad app-based audiometer is now available and CE marked (Shoebox MD, Clearwater Medical) that can be used by non-audiologists to test hearing in a standard outpatient setting. Furthermore a novel interactive web-based hearing app has recently been developed (3D Tune-In). This technology has not been used to date in an adult cohort such as people with cystic fibrosis.
We propose to analyse over a 12 month period at two adult cystic fibrosis centres in London whether outpatient tablet based audiometry testing and web-based hearing apps are able to accurately screen for ototoxicity in adults with CF, and whether these methods of screening are acceptable. We will determine whether this technology is as reliable as formal hearing tests and better than standard questionnaire-based screening. We will examine whether this approach can be used within the existing CF outpatient clinic by non-specialist staff to enable streamlining of care. Through this project we will also determine the incidence and significance of certain genetic mutations in predisposition to hearing loss in CF to inform further studies.
The results of this study will aim to streamline audiometry screening to improve detection rates, reduce cost of healthcare, enable equity in service delivery, and minimize disruption to the patient’s social and work-life using smart technology. The study is being sponsored by the NHS Darzi fellowship scheme and UK CF trust.
Trial Reference Number
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Length of participation
the length of time a participant will take part in a trial, from the first to the last appointment
Two visits which include three hearing tests, a blood test and questionnaires.
the name of the treatment or therapy being researched
the number of participants who need to be recruited for the trial in the UK
Last edited date
22 March 2019
Royal Brompton and Harefield NHS Foundation Trust
CF sponsor type