Evaluation of the High Frequency Digit Triplet Test in Cystic Fibrosis (NCT02252601) | Clinical Trial Compass
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Evaluation of the High Frequency Digit Triplet Test in Cystic Fibrosis
United Kingdom388 participantsStarted 2015-01
Plain-language summary
The purpose of this study is to find out whether the High Frequency Digit Triplet test can be used to screen patients with cystic fibrosis for hearing loss in conditions of health and pulmonary exacerbation. It is also designed to find out the youngest age at which a child can perform the test, the prevalence of hearing loss in a CF population and the prevalence of genetic mutations known to be associated with hearing loss in the same population.
Who can participate
Age range
5 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
Work stream 1
* A diagnosis of CF, confirmed by genotype or sweat test, with characteristic clinical features.
* Aged 11 years and over.
* Informed consent. For age 11 to 18 years, consent will be sought from both the parent and young person (provided the young person is competent).
Work stream 2
• As above but the participant has a pulmonary exacerbation (as defined by Fuch's criteria) requiring intravenous antibiotics.
Work stream 3
* As for work stream 1, defined above.
* CF patients aged 5-10 years
* Healthy control children aged 5-10 years.
* Informed consent from parent with assent from the child.
Genetic Testing
* Informed consent
* Diagnosis of CF as above
Exclusion criteria
* None. In individuals with a hearing aid, we will perform PTA and HFDT tests without the aid.
* Individuals found to have conductive deafness after randomisation will be fully assessed for this prior to continuing with the study.
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
Proportion of patients in whom the HFDT test accurately predicts the presence of absence of hearing loss.
Timeframe: 2 years
2
The youngest age at which 80% of children are able to perform the HFDT test.