Evaluation of the High Frequency Digit Triplet Test in Cystic Fibrosis (3D-CF)
Cystic Fibrosis, Sensorineural Hearing Loss
About this trial
This is an interventional screening trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, Hearing Loss, High Frequency Digit Triplet Test
Eligibility Criteria
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.
Sites / Locations
- Birmingham Children's Hospital NHS Foundation TrustRecruiting
- Heart of England NHS Foundation TrustRecruiting
- Nottingham University Hospitals NHS TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
Well patients aged 11 and over
Acute exacerbation aged 11 and over
Children with CF aged 5-10 years
Healthy Control Children age 5-10 years.
Will have the HFDT test compared to the gold standard (the Pure tone Audiogram) as well as other tests that have previously been suggested as a screening test for ototoxicity.
Will have the HFDT test compared to the gold standard (the Pure tone Audiogram) as well as other tests that have previously been suggested as a screening test for ototoxicity at the beginning of a course of IV antibiotics and at their convalescent clinic visit.
Will have the HFDT test compared to the gold standard (the Pure tone Audiogram) as well as other tests that have previously been suggested as a screening test for ototoxicity.
Will have the HFDT test compared to the gold standard (the Pure tone Audiogram) as well as other tests that have previously been suggested as a screening test for ototoxicity.