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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Intraclass correlation coefficient with 95% CI
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •• 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)
结局指标
主要结局
Intraclass correlation coefficient with 95% CI
时间窗: Through study completion, an average of 1 year
Reliability of tablet audiometry compared to gold-standard
次要结局
- Logistic regression modeling to identify risk factors for sensorineural hearing loss in adults with CF(Through study completion, an average of 1 year)
- Sensitivity, specificity of audiology screening tools(Through study completion, an average of 1 year)