Sleepiz One+ vs. Capnography and Electrocardiography
Recruiting · NCT06569940 · Interventional (participants receive a specific treatment) · Lead sponsor: Sleepiz AG
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Respiratory Rate (RR) and heart rate (HR) are vital signs crucial for assessing a patient's overall health, providing insights into various conditions and stressors. Effective management of chronic diseases relies on detecting pathological changes early, with RR being among the most sensitive predictors of patient deterioration. Therefore, vigilant monitoring of RR and HR is vital for improving patient outcomes. The primary aim of this study is to provide a thorough comparison of the performance of Sleepiz One+ algorithms and end-tidal carbon dioxide measurement (EtCO2) Capnography for measuring respiration rate and electrocardiography (ECG) for measuring heart rate, in healthy adults and patients suffering from chronic conditions (e.g., hypertension, Chronic Obstructive Pulmonary Disease (COPD), asthma, diabetes), at rest in a clinical setting when the data is acquired with the new hardware version. Additionally, the investigators will evaluate the performance of RR estimation against the thoracic effort belt and the HR against the pulse oximetry.
Who can take part
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
Where it is running
3 locations listed.
- Schlaflabor Fluntern - Zurich, Canton of Zurich, Switzerland
- Schlaflabor Fluntern - Zurich, Canton of Zurich, Switzerland
- Schlaflabor Fluntern - Zurich, Canton of Zurich, Switzerland