Asthma, COPD, Heart Diseases, Hypertension, Respiratory Disease, Sleep Apnea
Conditions
Brief 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, the performance of heart rate estimation will be evaluated against ECG.
Interventions
DEVICESleepiz One+
In 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 35 minutes.
Sponsors
Sleepiz AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
Annotators of capnography data were blinded to the values provided by the investigational device
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Respiration rate measurement accuracy per 60s epoch against visually scored capnography data, recorded on subjects lying down and resting on a bed. | 60s |
Countries
Switzerland
Outcome results
None listed