Sleep Apnea
Conditions
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.
Interventions
DEVICESleepiz One+ vs. polysomnography
Simultaneous sleep recording with polysomnography and Sleepiz One+ device
Sponsors
Sleepiz AG
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany
Outcome results
None listed