Validation of a Contactless Sensor for Sleep Apnea Diagnosis Against Polysomnography
| Registry | NCT04670848 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, diagnostic |
| Enrollment | 116 (Actual) |
| Sponsor | Sleepiz AG (Industry) |
| Conditions | Sleep Apnea |
| Interventions | Sleepiz One+ vs. polysomnography (Device) |
| Dates | start 2020-12-07, primary completion 2021-12-21, completion 2021-12-21, first posted 2020-12-17, last updated 2022-01-25 |
| Locations | 1 site in Germany |
Related Papers Related Patents Related Grants Related Experts
All trials for Sleep Apnea All trials of Sleepiz One+ vs. 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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Patients suspected of suffering from sleep apnea | Experimental | Device: Sleepiz One+ vs. polysomnography | |
| Healthy volunteers | Experimental | Device: Sleepiz One+ vs. polysomnography |
Sex: All, ages: 18 Years to any, accepts 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
| Facility | City | Country | Status |
|---|---|---|---|
| Universitätsmedizin Essen Ruhrlandklinik | Essen, North Rhine-Westphalia | Germany |