Validation of a Contactless Vital Signs Measurement Sensor

Sleepiz

Status

Completed

Conditions

Sleep Apnea

Treatments

Device: Polysomnography

Device: Sleepiz One+

Study type

Interventional

Funder types

Industry

Identifiers

NCT04676191

U1111-1248-9457

Details and patient eligibility

About

The primary aim of this study is to validate the performance of Sleepiz One+ for the measurement of vital physiological parameters in adult population, against a laboratory-based polysomnography. Additionally, the investigators will evaluate Sleepiz One+ ability to identify patients with a high risk of suffering from a sleep-related breathing disorder based on apnea-hypopnea index estimation. Participants will undergo measurement with Sleepiz One+ and a polysomnography device while resting in bed for 20 min as well as during sleep for the duration of the following night.

Enrollment

64 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age >18years
Ability and consent to undergo electrophysiological routine assessment
Informed Consent as documented by signature
Patients diagnosed or suspected to suffer from sleep apnea or any other sleep related disorder or patients suffering from chronic cardiac, respiratory or neuromuscular disorders
Ambulatory or stationary patients of Klinik Lengg

Exclusion criteria

Previous enrolment into the current study,
Enrolment of the investigator, his/her family members, employees and other dependent persons
Cardiac pacemaker or another implanted electrical device
Women who are pregnant
Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, delirium etc. of the participant