Evaluation of the High Frequency Digit Triplet Test in Cystic Fibrosis

Not Applicable

• Conditions: Cystic Fibrosis; Sensorineural Hearing Loss
• Interventions: Other: HFDT test; Other: Pure tone Audiogram

• Registration Number: NCT02252601
• Lead Sponsor: University of Nottingham

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-25
• Study First Posted: 2014-09-30
• Study Start: 2015-01
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-11
• Last Update Posted: 2016-04-12
• Primary Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 388

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Children with CF aged 5-10 years	Pure tone Audiogram	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.
Well patients aged 11 and over	HFDT test	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.
Healthy Control Children age 5-10 years.	HFDT test	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.
Acute exacerbation aged 11 and over	HFDT test	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.
Children with CF aged 5-10 years	HFDT test	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.
Well patients aged 11 and over	Pure tone Audiogram	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.
Healthy Control Children age 5-10 years.	Pure tone Audiogram	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.
Acute exacerbation aged 11 and over	Pure tone Audiogram	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.

Primary Outcome Measures

Name	Time	Method
Proportion of patients in whom the HFDT test accurately predicts the presence of absence of hearing loss.	2 years	This will be done in patients when they are clinically stable and at the beginning and end of a pulmonary exacerbation by comparing the HFDT test with the current gold standard test.
The youngest age at which 80% of children are able to perform the HFDT test.	2 years	This will be done in children aged 5-10 years and the

Secondary Outcome Measures

Name	Time	Method
The prevalence of hearing loss in a CF population.	2 years
The prevalence of genetic mutations that are associated with hearing loss in a CF population.	2 years

Trial Locations

Locations (3)

Birmingham Children's Hospital NHS Foundation Trust; 🇬🇧 Birmingham, United Kingdom

Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, United Kingdom

Heart of England NHS Foundation Trust; 🇬🇧 Birmingham, United Kingdom