Sleepiz One+ vs. Capnography and Electrocardiography
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSleepiz AG
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age >=18years
Informed Consent as documented by signature
One (or more) chronic medical condition/s (e.g., diabetes, asthma, cardiovascular or respiratory diseases, etc.)
Age >=18years
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Sleepiz One+
DeviceIn this study Sleepiz One+ will measure heart rate and respiration rate of a participant sitting or lying in different positions (right and left side, back, abdomen) on a bed. The recording will take around 42 minutes.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Sleepiz One+ vs. gold standardOther 1 intervention
Trial outcomes
Primary outcomes
1
Instantaneous respiration rate measurement accuracy per 60s epoch
Instantaneous respiration rate measurement accuracy per 60s epoch against visually scored capnography data, recorded on subjects lying down and resting on a bed
Time frame
During 60 seconds2
Instantaneous heart rate measurement accuracy per 60s epoch
Instantaneous heart rate measurement accuracy per 60s epoch against ECG R-R interval, recorded on subjects lying down and resting on a bed
Time frame
During 60 seconds Source ClinicalTrials.gov