Validation of two devices with optical sensor in healthy participants and patients with sleep wake disorders.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
69
Category A (ClinO). Medical study with CE-marked medical devices to photoplethysmographic measure heart rate, heart rate variability, and pulse wave and accelerometric data
University Hospital Bern (Inselspital), Department of Pulmonary Medicine
Bern, Switzerland
Total Sleep Time (TST) and sleep architecture (distribution of sleep stages)
Diagnostic accuracy of the new algorithm compared to the Gold Standard full polysomnography
Time frame: 1 night
The total time in non-REM sleep (stages 1-3), REM sleep, and awake after sleep onset
Diagnostic accuracy of the new algorithm compared to the Gold Standard full polysomnography
Time frame: 1 night
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