Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages

Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages: a Prospective, Method-comparison, Proof of Concept, Single-centre Phase IV Study

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.

Patients with sleep wake disorders

Inclusion Criteria:

• 18 ≤ Age ≤ 80 years
• Suspected sleep wake disorder (sleep apnea, sleep movement disorders, hypersomnia, parasomnia)
• Written informed consent

Exclusion Criteria:

• 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