Contactless Detection of Sleep Apnea
Not Applicable
Completed
- Conditions
- Sleep Apnea
- Interventions
- Device: Sleepiz One+ vs. polysomnography
- 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
- Arm && Interventions
Group Intervention Description Patients suspected of suffering from sleep apnea Sleepiz One+ vs. polysomnography - Healthy volunteers Sleepiz One+ vs. polysomnography -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Universitätsmedizin Essen Ruhrlandklinik
🇩🇪Essen, North Rhine-Westphalia, Germany