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

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Healthy; Sleep-Wake Disorders

Treatments: Device: OHR Tracker and PulseWatch

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03823105

2018-00917

Details and patient eligibility

About

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

Full description

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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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69 participants in 1 patient group

Nocturnal Recording

Experimental group

Description:

Recording of photoplethysmographic pulse wave and accelerometry with two devices (OHR Tracker, PulseWatch) in parallel to the standard polysomnography

Treatment:

Device: OHR Tracker and PulseWatch