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

NCT03823105 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2020-06-11

No results posted yet for this study

Summary

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

Conditions

  • Sleep-Wake Disorders
  • Healthy

Interventions

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

Sponsors & Collaborators

  • University of Bern

    collaborator OTHER

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

    collaborator INDUSTRY

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Sebastian R. Ott, MD · University Hospital Berne, Department of Pulmonary Medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-06
Primary Completion
2020-04-01
Completion
2020-06-10

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03823105 on ClinicalTrials.gov