Evaluation of the High Frequency Digit Triplet Test in Cystic Fibrosis

NCT02252601 | Unknown

• 2 other identifiers: 3D-CFPB-PG-0213-30055
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 3

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.

Conditions

Cystic Fibrosis; Sensorineural Hearing Loss

Keywords

Cystic Fibrosis; Hearing Loss; High Frequency Digit Triplet Test

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  2 years

Secondary Outcomes (2)

• The prevalence of hearing loss in a CF population.

  2 years

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

  2 years

Study Arms (4)

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.

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.

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.

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.

Other: HFDT test; Other: Pure tone Audiogram

Interventions

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

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead
• Nottingham University Hospitals NHS Trust: collaborator
• Heart of England NHS Trust: collaborator
• Birmingham Women's and Children's NHS Foundation Trust: collaborator

Study Sites (3)

Birmingham Children's Hospital NHS Foundation Trust

Birmingham, B 4 6NH, United Kingdom

RECRUITING

Heart of England NHS Foundation Trust

Birmingham, B9 5SS, United Kingdom

RECRUITING

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis; Hearing Loss, Sensorineural; Hearing Loss

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alan Smyth, MD

  The University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sally Palser, BMBS

CONTACT

+ 44 115 823 0618; sally.palser@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: September 30, 2014
• Study Start: January 1, 2015
• Primary Completion: July 1, 2018
• Last Updated: April 12, 2016

Record last verified: 2016-04

Locations

GB (3)