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

Study Overview
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Brief Summary
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Validation of two devices with optical sensor in healthy participants and patients with sleep wake disorders.

Detailed Description
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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.

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

Conditions
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Sleep-Wake Disorders, Healthy

Intervention / Treatment
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* Device: OHR Tracker and PulseWatch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nocturnal Recording<br>Recording of photoplethysmographic pulse wave and accelerometry with two devices (OHR Tracker, PulseWatch) in parallel to the standard polysomnography | Device: OHR Tracker and PulseWatch<br>* Category A (ClinO). Medical study with CE-marked medical devices to photoplethysmographic measure heart rate, heart rate variability, and pulse wave and accelerometric data<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sleep Time (TST) and sleep architecture (distribution of sleep stages) | Diagnostic accuracy of the new algorithm compared to the Gold Standard full polysomnography | 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 | 1 night | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep apnea, Hypersomnia, Parasomnia