Evaluation of the High Frequency Digit Triplet Test in Cystic Fibrosis

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Brief Title

Evaluation of the High Frequency Digit Triplet Test in Cystic Fibrosis

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

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 Type

Interventional


Primary Outcome

Proportion of patients in whom the HFDT test accurately predicts the presence of absence of hearing loss.

Secondary Outcome

 The prevalence of hearing loss in a CF population.

Condition

Cystic Fibrosis

Intervention

HFDT test

Study Arms / Comparison Groups

 Well patients aged 11 and over
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

388

Start Date

January 2015


Primary Completion Date

July 2018

Eligibility Criteria

        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.
      

Gender

All

Ages

5 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Alan Smyth, MD, + 44 115 823 0618, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT02252601

Organization ID

3D-CF

Secondary IDs

PB-PG-0213-30055

Responsible Party

Sponsor

Study Sponsor

University of Nottingham

Collaborators

 Nottingham University Hospitals NHS Trust

Study Sponsor

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


Verification Date

April 2016