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

NCT03823105 | Completed

• 1 other identifier: 2018-00917
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep-Wake Disorders; Healthy

Keywords

Sleep apnea; Hypersomnia; Parasomnia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Nocturnal Recording

EXPERIMENTAL

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

Device: OHR Tracker and PulseWatch

Interventions

OHR Tracker and PulseWatch 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

Nocturnal Recording

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator
• CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement: collaborator

Study Sites (1)

University Hospital Bern (Inselspital), Department of Pulmonary Medicine

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Apnea Syndromes; Disorders of Excessive Somnolence; Parasomnias

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Sebastian R. Ott, MD

  University Hospital Berne, Department of Pulmonary Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 30, 2019
• Study Start: December 6, 2018
• Primary Completion: April 1, 2020
• Study Completion: June 10, 2020
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

CH (1)