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

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ClinicalTrials.gov Identifier: NCT02252601
Recruitment Status : Unknown
Verified April 2016 by University of Nottingham.
Recruitment status was:  Recruiting
First Posted : September 30, 2014
Last Update Posted : April 12, 2016
Sponsor:
Collaborators:
Nottingham University Hospitals NHS Trust
Heart of England NHS Trust
Birmingham Women's and Children's NHS Foundation Trust
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Sensorineural Hearing Loss Other: HFDT test Other: Pure tone Audiogram Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 388 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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
Study Start Date : January 2015
Estimated Primary Completion Date : July 2018


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



Primary Outcome Measures :
  1. 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. 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


Secondary Outcome Measures :
  1. The prevalence of hearing loss in a CF population. [ Time Frame: 2 years ]
  2. The prevalence of genetic mutations that are associated with hearing loss in a CF population. [ Time Frame: 2 years ]


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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252601


Contacts
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Contact: Sally Palser, BMBS + 44 115 823 0618 ext 30618 sally.palser@nottingham.ac.uk

Locations
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United Kingdom
Birmingham Children's Hospital NHS Foundation Trust Recruiting
Birmingham, United Kingdom, B 4 6NH
Contact: Jane Clarke    +44 121 333 8208    jane.clarke@bch.nhs.uk   
Principal Investigator: Jane Clarke         
Heart of England NHS Foundation Trust Recruiting
Birmingham, United Kingdom, B9 5SS
Contact: Edward Nash    +44 121 424 1669    ed.nash@heartofengland.nhs.uk   
Principal Investigator: Ed Nash         
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG7 2UH
Contact: Alan Smyth, MD    + 44 115 823 0612    alan.smyth@nottingham.ac.uk   
Principal Investigator: Alan Smyth, FRCPCH, MD,         
Sponsors and Collaborators
University of Nottingham
Nottingham University Hospitals NHS Trust
Heart of England NHS Trust
Birmingham Women's and Children's NHS Foundation Trust
Investigators
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Principal Investigator: Alan Smyth, MD The University of Nottingham

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02252601     History of Changes
Other Study ID Numbers: 3D-CF
PB-PG-0213-30055 ( Other Grant/Funding Number: NIHR PB-PG-0213-30055 )
First Posted: September 30, 2014    Key Record Dates
Last Update Posted: April 12, 2016
Last Verified: April 2016

Keywords provided by University of Nottingham:
Cystic Fibrosis
Hearing Loss
High Frequency Digit Triplet Test

Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms