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Contactless Detection of Sleep Apnea

Primary Purpose

Sleep Apnea

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Sleepiz One+ vs. polysomnography

About this trial

This is an interventional diagnostic trial for Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Universitätsmedizin Essen Ruhrlandklinik

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Patients suspected of suffering from sleep apnea

Healthy volunteers

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04670848

First Posted

December 9, 2020

Last Updated

January 24, 2022

Sponsor

Sleepiz AG

1. Study Identification

Unique Protocol Identification Number

NCT04670848

Brief Title

Contactless Detection of Sleep Apnea

Official Title

Validation of a Contactless Sensor for Sleep Apnea Diagnosis Against Polysomnography

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

December 7, 2020 (Actual)

Primary Completion Date

December 21, 2021 (Actual)

Study Completion Date

December 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sleepiz AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

116 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients suspected of suffering from sleep apnea

Arm Type

Experimental

Arm Title

Healthy volunteers

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Sleepiz One+ vs. polysomnography

Intervention Description

Simultaneous sleep recording with polysomnography and Sleepiz One+ device

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christoph Schöbel, Prof. Dr. med.

Organizational Affiliation

Universitätsmedizin Essen Ruhrlandklinik

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universitätsmedizin Essen Ruhrlandklinik

City

Essen

State/Province

North Rhine-Westphalia

ZIP/Postal Code

45239

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Contactless Detection of Sleep Apnea

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