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临床试验/NCT06050720
NCT06050720已完成不适用

An Exploratory Study of a Novel, Low-cost Sleep Apnoea Screening Device to Compare Its Capability to Identify Apnoeas and Hypopneas With Current Standard Sleep Apnoea Test Devices

University Hospitals of North Midlands NHS Trust1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年3月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Breathing pressure changes

研究概览

简要总结

During sleep, many people have times when they breathe shallowly or completely stop. If a person stops breathing for more than 10 seconds, this is called an 'apnoea'. If shallow breathing lasts for more than 10 seconds, it is called a 'hypopnoea'. If a person has these events frequently, it disrupts their sleep and they do not awake refreshed. It can also put strain on the heart, leading to cardiovascular conditions. These sleep disorders, usually called 'Sleep Apnoea', can be treated for most people using 'continuous positive airways pressure', CPAP. Current tests for sleep apnoea, usually used at home, are expensive, complicated for patients to use and do not monitor actual breathing. The new test, called Apne-Scan, is very simple and will cost less than the standard tests. It just requires the user to wear a mask, similar to ones used for CPAP treatment, overnight and then send the mask off for data analysis. The Apne-Scan mask, developed with taxpayer funding, is fitted with a pressure sensor to monitor actual breathing. People between the ages of 18-70 who have been referred to the sleep clinic at Royal Stoke University Hospital are eligible to participate in this exploratory study. They will wear the Apne-Scan mask at the same time as their standard overnight sleep apnoea test. The breathing data collected by Apne-Scan will be analysed by Apnea-Tech Limited, the device manufacturers, so that it can be compared to the data captured by the standard sleep apnoea test.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have been referred by a clinician to the sleep clinic for diagnosis of a sleep disorder, possibly sleep apnoea.
  • Be about to be screened for possible sleep apnoea using a standard sleep apnoea test device.
  • Be between the ages of 18 and 75 and have provided informed consent for the study

排除标准

  • Have not been referred by a clinician to a sleep clinic for diagnostic tests for sleep disorders other than for possible sleep apnoea.
  • Cannot tolerate wearing a mask overnight.
  • Cannot remove a mask should they become distressed.
  • Are not capable of understanding the English language version of Apne-Scan's Instructions For Use (IFU).
  • Are under the age of 18 years old or over the age of 75 years old.
  • Are not capable of giving informed consent

研究组 & 干预措施

Sleep disorder patients

Other

The study participants have been referred by a clinician to the sleep clinic for diagnosis of a sleep disorder, possibly sleep apnoea.

干预措施: Apne-Scan DC1 device (Device)

结局指标

主要结局

Breathing pressure changes

时间窗: 2 months

The primary outcome of interest is the data capture of the changing pressures in the user's breathing, whilst asleep, as recorded by the Apne-Scan DC1 device

次要结局

  • Severity of hypopnoea(2 months)
  • Comparison between sleep apnoea devices(2 months)
  • Severity of sleep apnoea(2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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