Validation of a Contactless Vital Signs Measurement Sensor

January 24, 2022 updated by: Sleepiz AG

Single- Center Performance Assessment of a Contactless Sensor for Vital Physiological Parameters Measurement at Rest and Detection of Diagnostic Indices in Sleep Compared to Cardiorespiratory Polygraphy

The primary aim of this study is to validate the performance of Sleepiz One+ for the measurement of vital physiological parameters in adult population, against a laboratory-based polysomnography. Additionally, the investigators will evaluate Sleepiz One+ ability to identify patients with a high risk of suffering from a sleep-related breathing disorder based on apnea-hypopnea index estimation. Participants will undergo measurement with Sleepiz One+ and a polysomnography device while resting in bed for 20 min as well as during sleep for the duration of the following night.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >18years
  • Ability and consent to undergo electrophysiological routine assessment
  • Informed Consent as documented by signature
  • Patients diagnosed or suspected to suffer from sleep apnea or any other sleep related disorder or patients suffering from chronic cardiac, respiratory or neuromuscular disorders
  • Ambulatory or stationary patients of Klinik Lengg

Exclusion Criteria:

  • Previous enrolment into the current study,
  • Enrolment of the investigator, his/her family members, employees and other dependent persons
  • Cardiac pacemaker or another implanted electrical device
  • Women who are pregnant
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, delirium etc. of the participant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with sleep disorders, cardiorespiratory or neuromuscular disorders
Device: Sleepiz One+
Simultaneous sleep study with polysomnography and Sleepiz One+
Device: Polysomnography
Simultaneous sleep study with polysomnography and Sleepiz One+

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Respiration rate measurement accuracy agreement
Time Frame: 60 seconds
60 seconds

Secondary Outcome Measures

Outcome Measure
Time Frame
Binary classification of sleep apnea severity based on the AHI > 15 of Sleepiz One+ compared to results of Domino software and data manually scored by sleep technician
Time Frame: 1 Night
1 Night
Instantaneous respiration rate agreement between Sleepiz One+ and nasal cannula
Time Frame: 60 seconds
60 seconds
Average respiration rate agreement between Sleepiz One+ and thoracic respiratory effort belt
Time Frame: 1 Night
1 Night
Average respiration rate agreement between Sleepiz One+ and nasal cannula
Time Frame: 1 Night
1 Night
Sleep/wake classification agreement between Sleepiz One+ compared to polysomnography (PSG) data manually scored by sleep technician
Time Frame: 60 seconds
60 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sleepiz AG

Investigators

  • Principal Investigator: Bartosz Bujan, Dr. med., Klinik Lengg AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2020

Primary Completion (Actual)

February 2, 2021

Study Completion (Actual)

January 12, 2022

Study Registration Dates

First Submitted

December 9, 2020

First Submitted That Met QC Criteria

December 15, 2020

First Posted (Actual)

December 19, 2020

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 24, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1248-9457

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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