Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages: a Prospective, Method-comparison, Proof of Concept, Single-centre Phase IV Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- The total time in non-REM sleep (stages 1-3), REM sleep, and awake after sleep onset
研究概览
简要总结
Validation of two devices with optical sensor in healthy participants and patients with sleep wake disorders.
详细描述
The objective of this study is to evaluate and optimize a method of detecting sleep and sleep stages based on a new algorithm combining actigraphy and heart rate variability (measured by optical analysis of the pulse wave) to determine sleep architecture (segmented into three phases: WAKE, REM and NREM) with high accuracy compared to the gold standard polysomnography.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 ≤ Age ≤ 80 years
- •Suspected sleep wake disorder (sleep apnea, sleep movement disorders, hypersomnia, parasomnia)
- •Written informed consent
排除标准
- •Skin condition with eczema or damaged skin
- •Ischemia (cutaneous)
- •Allergy against nickel
- •Allergy against silicone
- •Current treatment with vasoactive drugs (e.g. beta-blockers, calcium channel antagonists, nitroglycerin, etc.) and/or antidepressive drugs (e.g. serotonin reuptake inhibitors, etc.).
- •Known infection with multiresistant bacteria
- •Implanted devices (e.g. pacemaker, pumps)
- •Rhythmogenic heart disease (e.g. resting heart rate > 120/min)
- •Severe or untreated arterial hypertension (blood pressure > 140mmHg systolic, >90mmHg diastolic)
- •Hypotension (blood pressure < 90mmHg systolic, < 60 mmHg diastolic)
- •Current alcohol or drug abuse, alcohol consumption the same day as the study
- •Consumption of coffee 7h before
- •Dark skin pigmentation
- •Severe metabolic disease (e.g. diabetes)
- •Pregnancy or lactation
- •Physical handicap effecting the two arms
- •Wound in the wrist region
- •Too large or too small wrist
- •Healthy subjects
- •Inclusion criteria:
- •18 ≤ Age ≤ 80 years
- •Written informed consent
- •Exclusion criteria:
- •Skin condition with eczema or damaged skin
- •Ischemia (cutaneous)
- •Allergy against nickel
- •Allergy against silicone
- •Any Medication (except birth control pill)
- •Known infection with multiresistant bacteria
- •Implanted devices (e.g. pacemaker, pumps)
- •Rhythmogenic heart disease (e.g. resting heart rate > 120/min)
- •Severe or untreated arterial hypertension (blood pressure > 140mmHg systolic, >90mmHg diastolic)
- •Hypotension (blood pressure < 90mmHg systolic, < 60 mmHg diastolic)
- •Current alcohol or drug abuse, alcohol consumption the same day as the study
- •Consumption of coffee 7h before
- •Implanted devices (e.g. pacemaker, pumps)
- •Known sleep-wake disorders
- •Dark skin pigmentation
- •Severe metabolic disease (e.g. diabetes)
- •Pregnancy or lactation
- •Physical handicap effecting the two arms
- •Wound in the wrist region
- •Too large or too small wrist
结局指标
主要结局
The total time in non-REM sleep (stages 1-3), REM sleep, and awake after sleep onset
时间窗: 1 night
Diagnostic accuracy of the new algorithm compared to the Gold Standard full polysomnography
Total Sleep Time (TST) and sleep architecture (distribution of sleep stages)
时间窗: 1 night
Diagnostic accuracy of the new algorithm compared to the Gold Standard full polysomnography
次要结局
未报告次要终点