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Contactless Detection of Sleep Apnea

Not Applicable
Completed
Conditions
Sleep Apnea
Registration Number
NCT04670848
Lead Sponsor
Sleepiz AG
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
116
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Binary classification of subjects based on their sleep apnea severity (AHI ≥= 15) made by Sleepiz One+, compared to PSG data manually scored by sleep technicians1 Night
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Universitätsmedizin Essen Ruhrlandklinik

🇩🇪

Essen, North Rhine-Westphalia, Germany

Universitätsmedizin Essen Ruhrlandklinik
🇩🇪Essen, North Rhine-Westphalia, Germany
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