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

May 22, 2020 updated by: Royal Brompton & Harefield NHS Foundation Trust

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intraclass correlation coefficient with 95% CI
Time Frame: Through study completion, an average of 1 year
Reliability of tablet audiometry compared to gold-standard
Through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sensitivity, specificity of audiology screening tools
Time Frame: Through study completion, an average of 1 year
as above
Through study completion, an average of 1 year
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
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Royal Brompton & Harefield NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
King's College Hospital NHS Trust
Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18/SC/0057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol and data available on request.

IPD Sharing Time Frame

Available on completion of study on request

IPD Sharing Access Criteria

Available on completion of study on request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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