Sleepiz One+ Versus Capnography and Electrocardiography

Single-center Evaluation of Sleepiz One+ in Measuring Respiration Rate and Heart Rate Compared to Gold Standard

EtCO2, or exhaled carbon dioxide, is a non-invasive and commonly used measure for respiratory rate and function. It can be easily monitored using a device called a capnograph, which consists of a sensor that is placed near the patient's mouth or nose and a monitor that displays the concentration of carbon dioxide in the respiratory gases in real-time.

EtCO2 capnography is generally considered a reliable and accurate method for monitoring respiration and is often used as a gold standard for comparing the performance of other methods for measuring respiration.

Therefore, the primary aim of this study is to provide a thorough comparison of the performance of Sleepiz One+ and EtCO2 Capnography for measuring respiration rate, in healthy adults and patients suffering from chronic conditions (e.g. hypertension, COPD, asthma, diabetes), at rest in a clinical setting. Additionally, the performance of heart rate estimation will be evaluated against ECG.

Inclusion Criteria:

Patients:

• Age >=18years
• Informed Consent as documented by signature
• One (or more) chronic medical condition/s (e.g., diabetes, asthma, cardiovascular or respiratory diseases, etc.)

Healthy volunteers

• Age >=18years
• Informed Consent as documented by signature
• No diagnosed chronic medical condition

Exclusion Criteria:

Patients

• Previous enrolment into the current study,
• 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

Healthy volunteers:

• Previous enrolment into the current study,
• 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
• Presence of diagnosed chronic medical condition