Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages
- Conditions
- Sleep-Wake DisordersHealthy
- Interventions
- Device: OHR Tracker and PulseWatch
- Registration Number
- NCT03823105
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- Brief Summary
Validation of two devices with optical sensor in healthy participants and patients with sleep wake disorders.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
- 18 ≤ Age ≤ 80 years
- Suspected sleep wake disorder (sleep apnea, sleep movement disorders, hypersomnia, parasomnia)
- Written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nocturnal Recording OHR Tracker and PulseWatch Recording of photoplethysmographic pulse wave and accelerometry with two devices (OHR Tracker, PulseWatch) in parallel to the standard polysomnography
- Primary Outcome Measures
Name Time Method The total time in non-REM sleep (stages 1-3), REM sleep, and awake after sleep onset 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) 1 night Diagnostic accuracy of the new algorithm compared to the Gold Standard full polysomnography
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Bern (Inselspital), Department of Pulmonary Medicine
🇨🇭Bern, Switzerland