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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy; Sleep-Wake Disorders
• Intervention / Treatment: Device: OHR Tracker and PulseWatch

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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • University Hospital Bern (Inselspital), Department of Pulmonary Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nocturnal Recording; Recording of photoplethysmographic pulse wave and accelerometry with two devices (OHR Tracker, PulseWatch) in parallel to the standard polysomnography	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: University of Bern; CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
• Investigators: Principal Investigator: Sebastian R. Ott, MD, University Hospital Berne, Department of Pulmonary Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2018
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): June 10, 2020

Study Registration Dates

• First Submitted: January 29, 2019
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 11, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Sleep apnea; Hypersomnia; Parasomnia
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders
• Other Study ID Numbers: 2018-00917

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No