Status:
UNKNOWN
Evaluation of the High Frequency Digit Triplet Test in Cystic Fibrosis
Lead Sponsor:
University of Nottingham
Collaborating Sponsors:
Nottingham University Hospitals NHS Trust
Heart of England NHS Trust
Conditions:
Cystic Fibrosis
Sensorineural Hearing Loss
Eligibility:
All Genders
5+ years
Phase:
NA
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 exacer...
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 F...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
388 Patients enrolled
Trial Details
Trial ID
NCT02252601
Start Date
January 1 2015
Last Update
April 12 2016
Active Locations (3)
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1
Birmingham Children's Hospital NHS Foundation Trust
Birmingham, United Kingdom, B 4 6NH
2
Heart of England NHS Foundation Trust
Birmingham, United Kingdom, B9 5SS
3
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG7 2UH