Evaluation of the High Frequency Digit Triplet Test in Cystic Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

388 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Determine the Incidence of Long QT Amongst a Large Cohort of Subjects Diagnosed With Unilateral or Bilateral Sensorineural Hearing Loss.

NCT02082431

Sensorineural Hearing Loss Long QT Syndrome

COMPLETED

Use of Frequency Compression in Severe-profound Hearing Loss Adults

NCT04623112

Frequency Compression Severe-profound Hearing Impairment

COMPLETED NA

Normal Values in Hearing and Balance Testing

NCT01629108

Healthy Volunteer

RECRUITING

Neonatal Hearing Screening at Neonatal Intensive Care Unit

NCT03716362

Hearing Loss

WITHDRAWN

Extended High-frequency Hearing and Speech Perception

NCT05435989

Low-pass Filtering Speech

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cystic Fibrosis Sensorineural Hearing Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HFDT test

Intervention Type OTHER

Pure tone Audiogram

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes