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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03823105
• Other study ID #: 2018-00917
• Status: Completed
• Phase: N/A
• Start date: December 6, 2018
• Est. completion date: June 10, 2020

Study information

• Verified date: June 2020
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: June 10, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Sleep Wake Disorders
• Sleep-Wake Disorders

Intervention

Device:
• OHR 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

Locations

Country	Name	City	State
Switzerland	University Hospital Bern (Inselspital), Department of Pulmonary Medicine	Bern

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement, University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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