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

NCT ID: NCT03823105

Last Updated: 2020-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-06
• Study Completion Date: 2020-06-10

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.

Conditions

Sleep-Wake Disorders; Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Nocturnal Recording

Recording of photoplethysmographic pulse wave and accelerometry with two devices (OHR Tracker, PulseWatch) in parallel to the standard polysomnography

Group Type: EXPERIMENTAL

OHR Tracker and PulseWatch

Intervention Type: DEVICE

Category A (ClinO). Medical study with CE-marked medical devices to photoplethysmographic measure heart rate, heart rate variability, and pulse wave and accelerometric data

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18 ≤ Age ≤ 80 years
• Suspected sleep wake disorder (sleep apnea, sleep movement disorders, hypersomnia, parasomnia)
• Written informed consent

• 18 ≤ Age ≤ 80 years
• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bern

OTHER

Sponsor Role: collaborator

CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement

INDUSTRY

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sebastian R. Ott, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Berne, Department of Pulmonary Medicine

Locations

University Hospital Bern (Inselspital), Department of Pulmonary Medicine

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

2018-00917

Identifier Type: -

Identifier Source: org_study_id