Sleepiz AG
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.
COPD
Hypertension
Sleep Apnea
Asthma
Heart Diseases
Respiratory Disease
Sleepiz One+
Not Applicable
Study Type : | Interventional |
Estimated Enrollment : | 36 participants |
Masking: | None (Open Label) |
Masking Description: | Annotators of capnography data were blinded to the values provided by the investigational device |
Primary Purpose: | Other |
Official Title: | Single-center Evaluation of Sleepiz One+ in Measuring Respiration Rate and Heart Rate Compared to Gold Standard |
Actual Study Start Date : | February 22, 2023 |
Estimated Primary Completion Date : | April 6, 2023 |
Estimated Study Completion Date : | April 6, 2023 |
Arm | Intervention/treatment |
---|---|
Other: Sleepiz One+ vs. gold standard Each enrolled participant will undergo a simultaneous recording with the Sleepiz One+, Capnography device and cardiorespiratory polygraphy with reduced number of channels (ECG and REB only) to measure respiration rate at and heart rate at rest, while sitting and lying down on a bed. |
Device: Sleepiz One+ |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Schlaflabor Fluntern
Zürich, Zurich, Switzerland, 8044