Evaluation of the High Frequency Digit Triplet test in Cystic Fibrosis

Details

Therapeutic approach
Other
Trial status
Closed with results Participating Centres
Trials Tracker ID
TT001506
Last updated
07/03/2019

Full 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.

Study details

The study will evaluate a new hearing test - the High Frequency Digit Triplet (HFDT) test. This test mimics how individuals hear in real life situations (such as a noisy room), requires only a computer and does not need clinically trained personnel. We will evaluate the new test in stable patients and in those about to receive intravenous antibiotics for a chest infection. We will also see if it is feasible to do the test in primary school children. If the HFDT test is accurate and practical we will apply for a new research grant which would allow us to see if the test is accurate when performed in the home (where there may be more background noise). We could then offer this test to every CF patient in the UK over 5 years. Patients could perform this test at home and then bring the result to discuss with their doctor if antibiotic treatment is likely. We believe this test could prevent hearing loss in many people with CF and allow substantial savings both in testing and in hearing aid provision (where hearing is irreversibly damaged).


Phase
Not applicable
Length of participation
1 day
Recruitment target
271
CF sponsor
University of Nottingham
CF sponsor type
Academic

Who can take part?

Age range
5 years and older
Including people

A diagnosis of CF, confirmed by genotype or sweat test, with characteristic clinical features
Aged 5 years and over

Excluding people

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.

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CF centres running this trial

Closed

Birmingham Children's Hospital

CTAP centre
NHS Trust
Birmingham Women's and Children's NHS Foundation Trust
Address
Steelhouse Lane
B4 6NH
Local site investigator
Maya Desai
Trial Coordinators
Aoife Neal
Closed

Birmingham Heartlands Hospital (Adults)

CTAP centre
NHS Trust
University Hospitals Birmingham NHS Foundation Trust
Address
Bordesley Green
B9 5SS
Local site investigator
Edward Nash
Trial Coordinators
Aoife Neal
Closed

Nottingham City Hospital (Adults)

CTAP centre
NHS Trust
Nottingham University Hospitals NHS Foundation Trust
Address
City Hospital, Wolfson Cystic Fibrosis Centre
Hucknall Road
NG5 1PB
Local site investigator
Alan Smyth
Trial Coordinators
Fozia Naushahi