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NCT04670848 Clinical Trial

Contactless Detection of Sleep Apnea

Sleep Apnea Clinical Trial

Official title:
Validation of a Contactless Sensor for Sleep Apnea Diagnosis Against Polysomnography

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04670848
Other study ID # PSG-Apnea-Essen
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 7, 2020
Est. completion date December 21, 2021

Study information
Verified date January 2022
Source Sleepiz AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 116
Est. completion date December 21, 2021
Est. primary completion date December 21, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Sleepiz One+ vs. polysomnography
Simultaneous sleep recording with polysomnography and Sleepiz One+ device

Locations
Country Name City State
Germany Universitätsmedizin Essen Ruhrlandklinik Essen North Rhine-Westphalia

Sponsors (1)
Lead Sponsor Collaborator
Sleepiz AG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 1 Night
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