Contactless Detection of Sleep Apnea

January 24, 2022 updated by: Sleepiz AG

Validation of a Contactless Sensor for Sleep Apnea Diagnosis Against Polysomnography

In this study the inestigators aim to validate the performance of Sleepiz One+ for sleep apnea detection during routine diagnostic sleep studies. Patients who are prescribed polysomnography study will be asked to participate and undergo a simultaneous sleep recording with radar sensor-based device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

116

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

  • Germany
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45239
        • Universitätsmedizin Essen Ruhrlandklinik

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >18years
  • Ability and consent to undergo electrophysiological routine assessment
  • Patients suspected to suffer from sleep apnea or any other sleep related disorder

Exclusion Criteria:

  • Previous enrollment into the current study,
  • Enrollment of the investigator, his/her family members and other dependent persons
  • Cardiac pacemaker or another implanted electrical device
  • Women who are pregnant or breastfeeding
  • 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: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients suspected of suffering from sleep apnea
Device: Sleepiz One+ vs. polysomnography
Simultaneous sleep recording with polysomnography and Sleepiz One+ device
EXPERIMENTAL: Healthy volunteers
Device: Sleepiz One+ vs. polysomnography
Simultaneous sleep recording with polysomnography and Sleepiz One+ device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Binary classification of subjects based on their sleep apnea severity (AHI ≥= 15) made by Sleepiz One+, compared to PSG data manually scored by sleep technicians
Time Frame: 1 Night
1 Night

Collaborators and Investigators

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

Sponsor

Sleepiz AG

Investigators

  • Principal Investigator: Christoph Schöbel, Prof. Dr. med., Universitätsmedizin Essen Ruhrlandklinik

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)

December 7, 2020

Primary Completion (ACTUAL)

December 21, 2021

Study Completion (ACTUAL)

December 21, 2021

Study Registration Dates

First Submitted

December 9, 2020

First Submitted That Met QC Criteria

December 15, 2020

First Posted (ACTUAL)

December 17, 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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSG-Apnea-Essen

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

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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