Status:
COMPLETED
Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
University of Bern
CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
Conditions:
Sleep-Wake Disorders
Healthy
Eligibility:
All Genders
18-80 years
Phase:
NA
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 analy...
Eligibility Criteria
Inclusion
- Patients with sleep wake disorders
- 18 ≤ Age ≤ 80 years
- Suspected sleep wake disorder (sleep apnea, sleep movement disorders, hypersomnia, parasomnia)
- Written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
December 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2020
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT03823105
Start Date
December 6 2018
End Date
June 10 2020
Last Update
June 11 2020
Active Locations (1)
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1
University Hospital Bern (Inselspital), Department of Pulmonary Medicine
Bern, Switzerland, 3010