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Completed

NCT Number: NCT04400955

A Study of Web and Tablet-based Interactive Audiometry in Adults With CF

Adults with CF regularly receive anti-infective therapy that can result in impaired hearing. Recent studies have identified that up to 50% of adults with CF have hearing loss with resulting significant impact on quality of life. At present, however, there is no national recommendation to screen for hearing loss within adult CF.

Formal hearing tests are costly, require specialist staff and equipment and require further outpatient visits resulting in significant impact on health, social and financial resource.

We propose to analyse over a 12 month period at two adult cystic fibrosis centres in London whether outpatient tablet based audiometry testing and web-based hearing apps are able to accurately screen for ototoxicity in adults with CF, and whether these methods of screening are acceptable. The results of this study will aim to streamline audiometry screening to improve detection rates, reduce cost of healthcare, enable equity in service delivery, and minimize disruption to the patient's social and work-life using smart technology.

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr Anand Shah

London, SW3 6NP, United Kingdom

About this study

Through a prospective multi-centre cross-sectional study, the utility of outpatient tablet-based audiometry (Shoebox MD, Clearwater Medical Ltd) and a novel interactive web-based hearing app developed in collaboration with the Dyson School of Audio design engineering, Imperial College (Project: 3D Tune-in) will be compared to standard sound-booth extended high-frequency audiometry performed by an audiologist and a validated ototoxicity screening questionnaire (HHIA). 200 adults with CF presenting either to the Specialist Adult Cystic Fibrosis Centre at the Royal Brompton and Harefield Foundation Trust or Kings College Hospital NHS Foundation Trust will be prospectively recruited to the study over a 12-month period. Blood samples for genomic DNA isolation will additionally be taken for all participants for mitochondrial DNA sequencing.

Hypothesis:

Tablet-based audiometry is a valid reliable tool to screen for drug-induced hearing loss in adults with CF.

Blinding:

  • Audiologists performing standard sound-booth extended high-frequency audiometry will be blinded to results of tablet-based audiometry and web-based hearing app results.

Outcome measures:

  • Warble-tone thresholds will be analysed through both tablet and standard extended high-frequency audiometry.
  • Interclass correlation coefficient (ICC) with a 95% confidence interval will be used as a measure of reliability.
  • Sensitivity, specificity and negative predictive value will be analysed to determine utility of tablet based audiometry, web-based hearing app, standardised hearing questionnaires and mitochondrial mutation screening to identify ototoxicity in adults with CF.
  • Logistic regression modelling (complex statistical modelling) will be used to determine risk factors for developing hearing loss within adult CF.
  • 7-point Likert scale questionnaires will be used to evaluate patient satisfaction, perceived usefulness and usability of tablet audiometry, web-based app hearing testing and formal audiometry.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients >16 years old under adult cystic fibrosis unit at Royal Brompton or King's college cystic fibrosis centres.

Ability to provide informed consent to participate in the study (written and witnessed).

Exclusion criteria

  • • Inability of patient to provide informed consent.
  • Patients with previously diagnosed visual impairment (due to web-based and tablet-based hearing app)
  • Established hearing loss with hearing aids in use (due to increased complexity of hearing tests required)
  • Inability to attend audiology outpatient appointments due to state of health.
  • Pregnancy (due to potential for reversible hearing loss during pregnancy affecting study reliability)

Treatment and study plan

Audiometry tablet diagnostic tool and web-based test

Diagnostic Test

as above

Primary outcomes

  1. Intraclass correlation coefficient with 95% CI

    Time frame: Through study completion, an average of 1 year

    Reliability of tablet audiometry compared to gold-standard

Secondary outcomes

  1. Sensitivity, specificity of audiology screening tools

    Time frame: Through study completion, an average of 1 year

    as above

  2. Logistic regression modeling to identify risk factors for sensorineural hearing loss in adults with CF

    Time frame: Through study completion, an average of 1 year

    as above

Sponsors and collaborators

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Other

Collaborators

  • Imperial College London
  • King's College Hospital NHS Trust

Registry information

Official study title

A Prospective Cross-sectional Study Analysing the Utility of Novel Tablet-based Audiometry and an Interactive Web-based Hearing App as Screening Tools for Drug-induced Ototoxicity in Adult Cystic Fibrosis

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 26, 2020
Registry last updated
May 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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