Hearing Loss, SensorineuralNCT04400955
A Study of Web and Tablet-based Interactive Audiometry in Adults With CF
An observational study of Hearing Loss, Sensorineural and Cystic Fibrosis, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hearing Loss, Sensorineural, Cystic Fibrosis
- What is being tested?
- Audiometry tablet diagnostic tool and web-based test
- Type of treatment
- Pill or oral medicine
- How many people
- 156 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2018to 1 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults with Cystic Fibrosis at Royal Brompton and Kings hospital London.
Who may be able to join
- 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).
Who cannot join
- • 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Hearing Loss, Sensorineural, Cystic Fibrosis
- Being tested
- Audiometry tablet diagnostic tool and web-based test
- Medical subject headings
- Hearing Loss, Sensorineural, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiometry tablet diagnostic tool and web-based testDiagnostic test
as above
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraclass correlation coefficient with 95% CI
Reliability of tablet audiometry compared to gold-standard
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Sensitivity, specificity of audiology screening tools
as above
Measured: Through study completion, an average of 1 year
Logistic regression modeling to identify risk factors for sensorineural hearing loss in adults with CF
as above
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start1 Mar 2018
- Primary completion1 Mar 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London, King's College Hospital NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400955
- Sponsor's protocol ID
- 18/SC/0057
- Status last verified
- May 2020
- First submitted
- 13 Feb 2020
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and data available on request.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04400955
- Acronym / sponsor ID
- 18/SC/0057
- Conditions
- Hearing Loss, Sensorineural, Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Imperial College London, King's College Hospital NHS Trust
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 26 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults with Cystic Fibrosis at Royal Brompton and Kings hospital London.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- • Inability of patient to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audiometry tablet diagnostic tool and web-based testas above | Diagnostic test | – |
Primary outcome
Intraclass correlation coefficient with 95% CI
Time frame: Through study completion, an average of 1 year
Reliability of tablet audiometry compared to gold-standard
2 secondary outcomes
Sensitivity, specificity of audiology screening tools
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Individual participant dataSharing planned: Yes. Study protocol and data available on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Sensorineural and Cystic Fibrosis, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraclass correlation coefficient with 95% CI (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2020.