Evaluation of the High Frequency Digit Triplet Test in Cystic Fibrosis (3D-CF)

April 11, 2016 updated by: University of Nottingham

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

388

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Recruiting
        • Heart of England Nhs Foundation Trust
        • Contact:
        • Principal Investigator:
          • Ed Nash
      • Birmingham, United Kingdom, B 4 6NH
        • Recruiting
        • Birmingham Children's Hospital NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Jane Clarke
      • Nottingham, United Kingdom, NG7 2UH
        • Recruiting
        • Nottingham University Hospitals NHS Trust
        • Contact:
        • Principal Investigator:
          • Alan Smyth, FRCPCH, MD,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Well patients aged 11 and over
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.
Other: HFDT test
Other: Pure tone Audiogram
Experimental: Acute exacerbation aged 11 and over
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.
Other: HFDT test
Other: Pure tone Audiogram
Experimental: Children with CF aged 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.
Other: HFDT test
Other: Pure tone Audiogram
Active Comparator: 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.
Other: HFDT test
Other: Pure tone Audiogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients in whom the HFDT test accurately predicts the presence of absence of hearing loss.
Time Frame: 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.
2 years
The youngest age at which 80% of children are able to perform the HFDT test.
Time Frame: 2 years
This will be done in children aged 5-10 years and the
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The prevalence of hearing loss in a CF population.
Time Frame: 2 years
2 years
The prevalence of genetic mutations that are associated with hearing loss in a CF population.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Collaborators

Nottingham University Hospitals NHS Trust
Birmingham Women's and Children's NHS Foundation Trust
Heart of England NHS Trust

Investigators

  • Principal Investigator: Alan Smyth, MD, The University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

September 17, 2014

First Submitted That Met QC Criteria

September 25, 2014

First Posted (Estimate)

September 30, 2014

Study Record Updates

Last Update Posted (Estimate)

April 12, 2016

Last Update Submitted That Met QC Criteria

April 11, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3D-CF
  • PB-PG-0213-30055 (Other Grant/Funding Number: NIHR PB-PG-0213-30055)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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