The Automated Mobile Interactive Audiometer - Feasibility and Reliability in a Clinical Setting
研究概览
详细说明
In the 2011 report on Disability, the World Health Organization rated hearing loss as the most prevalent disability in the world. More than 30% of adults have disabling hearing loss complicating the management of their comorbid diseases. Isolation, mental illness and lack of family support are just some of the negative impacts of this invisible disability. In the next 25 years the number of hearing impaired individuals over the age of 65 in Canada will double, while at the same time there is a projected 50% shortfall in audiological service providers. The resultant service deficit is compounded by the lack of equipment and familiarity with hearing healthcare at the primary care level, causing increased inefficiency, unnecessary referrals, and unmet needs.
In Canada, there is a critical need to improve the number of health professionals with the requisite skills to meet the needs of the aging population. This project is aimed at developing a novel approach to address the increasing need for hearing healthcare in the adults while managing the strain on the healthcare system.
Healthcare workers (such as general practitioners, registered nurses and allied heath workers) can play an important role in supporting and motivating adults to seek help and aid in the referral process. However, few healthcare workers receive formal training in the identification, diagnosis, treatment options, referral process, and special needs of older adults with hearing loss. This lack of training, resources and equipment is a significant gap in the care provided to the elderly and impacts all other aspects of elder care.
Undiagnosed/untreated hearing loss can lead to physiological changes associated with auditory deprivation, as well as psychosocial changes of social isolation and depression. It can result in emotional, physical, cognitive, and behavioral consequences including impaired activities of daily living, decline in independence and reduced quality of life. In spite of the prevalence and impact of hearing loss and the benefits of rehabilitation in reducing the psychological, social, and emotional consequences of hearing loss, referral by physicians for assessment and rehabilitation is low and the majority of adults who could benefit from the use of hearing aids do not use this technology. Early identification can help to reduce these deleterious effects, and lead to easier adjustment to hearing aid use.
In spite of the numerous recent technological advances in field of hearing amplification devices, current technologies may not be effective for older adults who have central auditory processing and cognitive processing difficulties. Additionally, untreated hearing loss lowers performance on aurally administered diagnostic tests used to quantify the severity of dementia and can significantly confound the clinical picture in this population. Furthermore, the use of amplification is associated with reduction in problem behavior in persons with a primary diagnosis of Alzheimer's disease and a reduction in hearing handicap for persons with Alzheimer's disease and their significant others.
This study aims to validate the use of a tablet based audiometer to provide an accurate, efficient, and cost-effective means for diagnosis of hearing conditions in controlled and uncontrolled environments in adult and elderly populations.
Observations between the soundbooth and iPad audiograms will include the following frequencies 250, 500, 1000, 2000, 4000, 6000 and 8000 Hz. Each iPad audiogram consists of an interactive game that takes approximately 10-20 minutes to complete. The conventional audiogram will take place before the iPad audiogram. We expect our study to add a maximum of 20-30 minutes to each enrolled patient's visit. The iPad audiogram observations will not be used by the patient's physician for diagnostic and treatment purposes.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Ontario
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Ottawa、Ontario、加拿大、K1Y 4E9
- 招聘中
- The Ottawa Hospital Civic and General Campuses
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- For Group I and II all adults over the age of 18 years who attend an Audiology clinic for conventional Audiometry at the Civic campus will be eligible for this study.
- For Group III adults over the age of 18 years who attend ENT clinic but aren't undergoing conventional audiometric testing will be eligible.
Exclusion Criteria:
- Patients who self report being unable to play the iPad game.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
Automated Mobile Interactive Audiometer, Test Retest
Each participant will act as his/her own control.
The iPad audiogram will be compared to the audiogram in sound booth or to a second iPad audiogram.
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iPad game
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Automated Mobile Interactive Audiometer, Validation.
iPad testing will be compared to conventional audiometry in the sound booth.
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iPad game
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Automated Mobile Interactive Audiometer, Speech Recognition
Testing with NU-6 word lists will be conducted by the iPad and by an audiologist in the sound booth.
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iPad game
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Automated Mobile Interactive Audiometer, Cochlear Implant
Participants with cochlear implants will be tested using iPad against conventional audiometry (warble tone) in the sound booth.
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iPad game
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Validate the use of an iPad audiometer for hearing testing in adults aged 18 and older in Ottawa, Canada.
大体时间:8 months
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iPad audiogram will be compared to conventional audiogram (sound booth) and test/retest reliability of the iPad will be measured in Group 3.
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8 months
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合作者和调查者
调查人员
- 首席研究员:David Schramm, MD、The Ottawa Hospital
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.