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

NCT04400955 | Completed

• 1 other identifier: 18/SC/0057
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hearing Loss, Sensorineural; Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Intraclass correlation coefficient with 95% CI

  Reliability of tablet audiometry compared to gold-standard

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Sensitivity, specificity of audiology screening tools

  Through study completion, an average of 1 year

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

  Through study completion, an average of 1 year

Interventions

Audiometry tablet diagnostic tool and web-based test DIAGNOSTIC_TEST

as above

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with Cystic Fibrosis at Royal Brompton and Kings hospital London.

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• Imperial College London: collaborator
• King's College Hospital NHS Trust: collaborator

Study Sites (1)

Dr Anand Shah

London, SW3 6NP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood for genomic DNA extraction

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Cystic Fibrosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: May 26, 2020
• Study Start: March 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: June 1, 2019
• Last Updated: May 26, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Available on completion of study on request
• Access Criteria: Available on completion of study on request

Locations

GB (1)