Healthy, Sleep-Wake Disorders
Conditions
Keywords
Sleep apnea, Hypersomnia, Parasomnia
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.
Interventions
DEVICEOHR Tracker and PulseWatch
Category A (ClinO). Medical study with CE-marked medical devices to photoplethysmographic measure heart rate, heart rate variability, and pulse wave and accelerometric data
Sponsors
University of Bern
CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Switzerland
Outcome results
None listed