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

Primary Purpose

Cystic Fibrosis, Sensorineural Hearing Loss

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
HFDT test
Pure tone Audiogram
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, Hearing Loss, High Frequency Digit Triplet Test

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Birmingham Children's Hospital NHS Foundation TrustRecruiting
  • Heart of England NHS Foundation TrustRecruiting
  • Nottingham University Hospitals NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Well patients aged 11 and over

Acute exacerbation aged 11 and over

Children with CF aged 5-10 years

Healthy Control Children age 5-10 years.

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

The prevalence of hearing loss in a CF population.
The prevalence of genetic mutations that are associated with hearing loss in a CF population.

Full Information

First Posted
September 17, 2014
Last Updated
April 11, 2016
Sponsor
University of Nottingham
Collaborators
Nottingham University Hospitals NHS Trust, Heart of England NHS Trust, Birmingham Women's and Children's NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02252601
Brief Title
Evaluation of the High Frequency Digit Triplet Test in Cystic Fibrosis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
Nottingham University Hospitals NHS Trust, Heart of England NHS Trust, Birmingham Women's and Children's NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Sensorineural Hearing Loss
Keywords
Cystic Fibrosis, Hearing Loss, High Frequency Digit Triplet Test

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
388 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Well patients aged 11 and over
Arm Type
Experimental
Arm 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.
Arm Title
Acute exacerbation aged 11 and over
Arm Type
Experimental
Arm 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 at the beginning of a course of IV antibiotics and at their convalescent clinic visit.
Arm Title
Children with CF aged 5-10 years
Arm Type
Experimental
Arm 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.
Arm Title
Healthy Control Children age 5-10 years.
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
HFDT test
Intervention Type
Other
Intervention Name(s)
Pure tone Audiogram
Primary Outcome Measure Information:
Title
Proportion of patients in whom the HFDT test accurately predicts the presence of absence of hearing loss.
Description
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.
Time Frame
2 years
Title
The youngest age at which 80% of children are able to perform the HFDT test.
Description
This will be done in children aged 5-10 years and the
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The prevalence of hearing loss in a CF population.
Time Frame
2 years
Title
The prevalence of genetic mutations that are associated with hearing loss in a CF population.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sally Palser, BMBS
Phone
+ 44 115 823 0618
Ext
30618
Email
sally.palser@nottingham.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Smyth, MD
Organizational Affiliation
The University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birmingham Children's Hospital NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B 4 6NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Clarke
Phone
+44 121 333 8208
Email
jane.clarke@bch.nhs.uk
First Name & Middle Initial & Last Name & Degree
Jane Clarke
Facility Name
Heart of England NHS Foundation Trust
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Nash
Phone
+44 121 424 1669
Email
ed.nash@heartofengland.nhs.uk
First Name & Middle Initial & Last Name & Degree
Ed Nash
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Smyth, MD
Phone
+ 44 115 823 0612
Email
alan.smyth@nottingham.ac.uk
First Name & Middle Initial & Last Name & Degree
Alan Smyth, FRCPCH, MD,

12. IPD Sharing Statement

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Evaluation of the High Frequency Digit Triplet Test in Cystic Fibrosis

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