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临床试验/NCT05049135
NCT05049135已完成不适用

Long Distance Diagnostics of Sleep Apnea With Objective Sleep Data From a Sensor-less Monitor - a Feasibility Study

Helse Nord-Trøndelag HF1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
1
主要终点
Apnea/hypopnea index

研究概览

简要总结

To evaluate the feasibility of a sensor-less sleep monitor (Somnofy®) in diagnosis and follow-up in obstructive sleep apnea. The study will explore the monitor's usefulness in detection of apnea during sleep, and compare the data to standard diagnostic registrations.

详细描述

A single-center prospective feasibility study. The study device is Somnofy®, a sensor-less commercially available sleep monitor. The ability of the monitor to detect apneas or hypopneas based on ultra wideband radar technology will be evaluated. The Somnofy® radar data will be compared with the diagnostic data from the predicate polygraph device NOX-T3 and the OSAS event data from the Metronics AirView software from CPAP. Thus, it will be possible to assess if Somnofy® is able to detect the events registered from the diagnostic equipment. For patients started on Continous Positive Airway Pressure (CPAP) treatment, a new registration with Somnofy® will be performed 12 weeks after treatment initiation. The effect of obstructive sleep apnea on patient and partner reported outcomes before and after CPAP initiation will also be assessed through questionnaires and journals.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • referred to the pulmonology department in the participating hospital (Sykehuset Levanger) with suspected sleep apnea
  • able to sign an informed consent

排除标准

  • Pregnancy
  • Serious disease which could affect ability to complete the study
  • Complicated sleep disorders

结局指标

主要结局

Apnea/hypopnea index

时间窗: 72 hours

Apnea/hypopnea index defined as the number of apneas or hypopneas per hours of sleep

次要结局

  • Sleep score(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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