Cystic Fibrosis Clinical Trial
Official title:
An Evaluation of the High Frequency Digit Triplet Test as a Screening Tool for Early Detection of Hearing Loss in Individuals With Cystic Fibrosis
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.
Patients will be identified from the clinic list of four Cystic Fibrosis centres (Nottingham
University Hospitals NHS (National Health Service) Trust, adults and children, West Midlands
Adult Cystic Fibrosis Centre and Birmingham Children's Hospital).
In the first work stream patients 11 years old and over will answer some hearing screening
questions and an ear examination and tympanogram. They will then have the new test (the High
Frequency Digit Triplet, HFDT, test), the standard tests (Pure tone audiogram (PTA)
including high frequencies, Distortion Product Otoacoustic Emissions) and then repeat the
new test to look for order effect. These will be compared to validate the HFDT as a
screening tool for hearing loss.
In the second work stream the investigators are looking to see if the test is feasible when
a patient is unwell and about to start a course of IV antibiotics. The patients will have
the same tests as in work stream 1 (though the high-frequency PTA may be modified if they
are too unwell to complete it). They will then have the tests repeated at the next clinic
visit (approximately 6-8 weeks later).
In the third work stream children aged 5-10 years will have the same tests. This is to
discover the youngest age at which the HFDT test can reliably be performed. To ensure that
the CF condition does not itself affect the ability to perform the test the investigators
will compare CF children to healthy control children the same age.
The investigators will take blood and saliva samples from CF patients to look for mutations
in mitochondrial genes which are known to be associated with aminoglycoside induced hearing
loss.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
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