A Study of Web and Tablet-based Interactive Audiometry in Adults With CF (NCT04400955) | Clinical Trial Compass
CompletedNot Applicable
A Study of Web and Tablet-based Interactive Audiometry in Adults With CF
United Kingdom156 participantsStarted 2018-03-01
Plain-language summary
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.
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. 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.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All patients \>16 years old under adult cystic fibrosis unit at Royal Brompton or King's college cystic fibrosis centres.
Ability to provide informed consent to participate in the study (written and witnessed).
Exclusion Criteria:
* • Inability of patient to provide informed consent.
* Patients with previously diagnosed visual impairment (due to web-based and tablet-based hearing app)
* Established hearing loss with hearing aids in use (due to increased complexity of hearing tests required)
* Inability to attend audiology outpatient appointments due to state of health.
* Pregnancy (due to potential for reversible hearing loss during pregnancy affecting study reliability)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intraclass correlation coefficient with 95% CI
Timeframe: Through study completion, an average of 1 year
Trial details
NCT IDNCT04400955
SponsorRoyal Brompton & Harefield NHS Foundation Trust