Contactless Detection of Sleep Apnea

Sleepiz

Status: Completed

Conditions: Sleep Apnea

Treatments: Device: Sleepiz One+ vs. polysomnography

Study type: Interventional

Funder types: Industry

Identifiers

NCT04670848

PSG-Apnea-Essen

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Patients suspected of suffering from sleep apnea

Experimental group

Treatment:

Device: Sleepiz One+ vs. polysomnography

Healthy volunteers

Experimental group

Treatment:

Device: Sleepiz One+ vs. polysomnography