Evaluation of the High Frequency Digit Triplet Test in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— 3D-CF  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02252601
• Other study ID #: 3D-CF
• Secondary ID: PB-PG-0213-30055
• Status: Recruiting
• Phase: N/A
• First received: September 17, 2014
• Last updated: April 11, 2016
• Start date: January 2015

Study information

• Verified date: April 2016
• Source: University of Nottingham
• Contact: Sally Palser, BMBS
• Phone: + 44 115 823 0618
• Email: sally.palser[@]nottingham.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 388
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Cystic Fibrosis
• Deafness
• Fibrosis
• Hearing Loss
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss

Intervention

Other:
• HFDT test

• Pure tone Audiogram

Locations

Country	Name	City	State
United Kingdom	Birmingham Children's Hospital NHS Foundation Trust	Birmingham
United Kingdom	Heart of England NHS Foundation Trust	Birmingham
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham

Sponsors (4)

Lead Sponsor	Collaborator
University of Nottingham	Birmingham Children's Hospital NHS Foundation Trust, Heart of England NHS Trust, Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients in whom the HFDT test accurately predicts the presence of absence of hearing loss.	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.	2 years	No
Primary	The youngest age at which 80% of children are able to perform the HFDT test.	This will be done in children aged 5-10 years and the	2 years	No
Secondary	The prevalence of hearing loss in a CF population.		2 years	No
Secondary	The prevalence of genetic mutations that are associated with hearing loss in a CF population.		2 years	No