Mixed Methods Evaluation of a Novel Apnoea Event Detection Monitor
A Mixed-methods Evaluation of a Novel Apnoea Event Detection Monitor in Comparison to Standard of Care Limited Overnight Polysomnography
This investigation is looking at a currently available technology to see if it could have another use i.e. in helping to diagnose patients with sleep apnoea.
With 2-4% of the population suffering from this disease, and the current wait time for a test at approximately 20 weeks, it is hoped that a simple screening method could help speed up the process of finding these patients and getting them on treatment faster.
The current standard of care test involves a sleep study in the patients own home with a device with multiple parts and wires. The RespiraSense Sleep Screener is completely cableless and consists of one small, discrete unit attached to the patients side and a mobile device plugged in by the bed.
Patients at Queen Alexandra Hospital who are prescribed sleep studies will be invited to participate. The RespiraSense Sleep Screener data is only for comparison purposes and will have no effect on their clinical care.
If patients agree to participate they will undergo the sleep study with both devices in the same night and may be followed up with over the phone on their experiences with the test.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Portsmouth、英国、PO6 3LY
- Queen Alexandra Hospital
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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:
- Patients ≥ 18 Years
- Patients due to undergo home monitoring to investigate presence of sleep apnoeic events
- Patients able to provide informed consent to participate in this investigation
Exclusion Criteria:
- Patients with known respiratory disorders that are uncontrolled at the time of the sleep study
- Patients allergic to medical grade skin adhesive
- Patients on long term, oral steroid use
- Pregnant women during second and third trimester
- Patients presently on any sleep disorder therapy
- Patients with any history of substance abuse (drug or alcohol) that may interfere with their ability to cooperate and comply with the investigation procedures
- Patients with any disorder, including cognitive dysfunction, which would affect the ability to accurately complete questionnaires and freely give full informed consent
学习计划
研究是如何设计的？
设计细节
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 |
|---|---|---|
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Similarity to standard of care
大体时间：One night
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The mean error of the device relative to the overnight polysomnography tests ≥ 10 AHI
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One night
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Qualitative evaluation of RespiraSense
大体时间：One night
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to qualitatively evaluate the perceptions, values and opinions of the RS Sleep Screener device compared with the comparator to identify potential modifications to improve patient acceptance and to inform future implementation of the device within the NHS setting
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One night
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合作者和调查者
调查人员
- 首席研究员：Anoop Chauhan、Portsmouth Hospitals NHS Trust
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
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
与本研究相关的术语
其他研究编号
- PMD-CS-008
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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RespiraSense Sleep Screener的临床试验
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Temple UniversityNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)完全的
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Advancing Clinical Trials in Neonatal Opioid Withdrawal...National Institutes of Health (NIH)主动，不招人