Cystic Fibrosis3D-CFNCT02252601
Evaluation of the High Frequency Digit Triplet Test in Cystic Fibrosis
A study testing HFDT test and Pure tone Audiogram in people with Cystic Fibrosis and Sensorineural Hearing Loss, run by University of Nottingham at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Sensorineural Hearing Loss
- What is being tested?
- HFDT test and Pure tone Audiogram
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jan 2015to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
Birmingham Children's Hospital NHS Foundation Trust
Birmingham, B 4 6NH
Jane Clarke, +44 121 333 8208, jane.clarke@bch.nhs.uk
Jane Clarke
- Recruiting
Heart of England NHS Foundation Trust
Birmingham, B9 5SS
Edward Nash, +44 121 424 1669, ed.nash@heartofengland.nhs.uk
Ed Nash
- Recruiting
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
Alan Smyth, MD, + 44 115 823 0612, alan.smyth@nottingham.ac.uk
Alan Smyth, FRCPCH, MD,
About this study
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
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.
Read the 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.
- Conditions
- Cystic Fibrosis, Sensorineural Hearing Loss
- Being tested
- HFDT test, Pure tone Audiogram
- Keywords
- Cystic Fibrosis, Hearing Loss, High Frequency Digit Triplet Test
- Medical subject headings
- Cystic Fibrosis, Hearing Loss, Sensorineural, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFDT testOther
Pure tone AudiogramOther
| Study group | Role | What they receive |
|---|---|---|
| Well patients aged 11 and over | Experimental | 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. Receives: Other: HFDT test; Other: Pure tone Audiogram |
| Acute exacerbation aged 11 and over | Experimental | 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. Receives: Other: HFDT test; Other: Pure tone Audiogram |
| Children with CF aged 5-10 years | Experimental | 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. Receives: Other: HFDT test; Other: Pure tone Audiogram |
| Healthy Control Children age 5-10 years. | Active comparator | 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. Receives: Other: HFDT test; Other: Pure tone Audiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
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
Measured: 2 years
Secondary outcomes (2)
The prevalence of hearing loss in a CF population.
Measured: 2 years
The prevalence of genetic mutations that are associated with hearing loss in a CF population.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startJan 2015
- Primary completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 388 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, Heart of England NHS Trust, Birmingham Women's and Children's NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Alan Smyth, MD, Principal investigator, The University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252601
- Sponsor's protocol ID
- 3D-CF
- Other IDs
- PB-PG-0213-30055
- Acronym
- 3D-CF
- Status last verified
- Apr 2016
- First submitted
- 17 Sep 2014
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02252601
- Acronym / sponsor ID
- 3D-CF / 3D-CF
- Conditions
- Cystic Fibrosis, Sensorineural Hearing Loss
- Keywords
- Cystic Fibrosis, Hearing Loss, High Frequency Digit Triplet Test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 388 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, Heart of England NHS Trust, Birmingham Women's and Children's NHS Foundation Trust
- Study start
- Jan 2015
- Primary completion
- Jul 2018 (estimated)
- First posted
- 30 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Well patients aged 11 and over | Experimental | Other: HFDT test, Other: Pure tone AudiogramWill 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. |
| Acute exacerbation aged 11 and over | Experimental | Other: HFDT test, Other: Pure tone AudiogramWill 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. |
| Children with CF aged 5-10 years | Experimental | Other: HFDT test, Other: Pure tone AudiogramWill 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. |
| Healthy Control Children age 5-10 years. | Active comparator | Other: HFDT test, Other: Pure tone AudiogramWill 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. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFDT test | Other | Acute exacerbation aged 11 and over, Children with CF aged 5-10 years, Healthy Control Children age 5-10 years., Well patients aged 11 and over |
| Pure tone Audiogram | Other | Acute exacerbation aged 11 and over, Children with CF aged 5-10 years, Healthy Control Children age 5-10 years., Well patients aged 11 and over |
Primary outcome
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.
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 secondary outcomes
The prevalence of hearing loss in a CF population.
Time frame: 2 years
The prevalence of genetic mutations that are associated with hearing loss in a CF population.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Smyth, MD principal investigator
The University of Nottingham
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFDT test and Pure tone Audiogram in people with Cystic Fibrosis and Sensorineural Hearing Loss, run by University of Nottingham at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sally Palser, BMBS (+ 44 115 823 0618 ext. 30618, sally.palser@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients in whom the HFDT test accurately predicts the presence of absence of hearing loss. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2016.