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NCT05712226
Sleepiz One+ Versus Capnography and Electrocardiography
Conditions: COPD, Hypertension, Sleep Apnea, Asthma, Heart Diseases, Respiratory Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 35
Sponsor: Sleepiz AG
Summary
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, we will evaluate the performance of heart rate estimation against ECG.
Eligibility Criteria
Inclusion Criteria:Patients:Age >=18yearsInformed Consent as documented by signatureOne (or more) chronic medical condition/s (e.g., diabetes, asthma, cardiovascular or respiratory diseases, etc.)Healthy volunteersAge >=18yearsInformed Consent as documented by signatureNo diagnosed chronic medical conditionExclusion Criteria:PatientsPrevious enrolment into the current study,Cardiac pacemaker or another implanted electrical deviceWomen who are pregnant or breastfeedingInability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, delirium etc. of the participantHealthy volunteers:Previous enrolment into the current study,Cardiac pacemaker or another implanted electrical deviceWomen who are pregnant or breastfeedingInability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, delirium etc. of the participantPresence of diagnosed chronic medical condition
Source: ClinicalTrials.gov (NCT05712226). StuddyBuddy aggregates publicly available trial information.