An interventional study of Sleepiz One+ in COPD, Hypertension and Sleep Apnea, sponsored by Sleepiz AG. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-08.
Sponsored by Sleepiz AG · Not applicable, Interventional, and Other
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.
617 studies on the registry are indexed under Respiratory Tract Diseases; 111 are open to participants now.
This study's enrollment of 36 is below the median of 80 across 381 interventional studies indexed under Respiratory Tract Diseases.
Browse Respiratory Tract Diseases studies →Sleepiz AG is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Patients:
Healthy volunteers
Exclusion Criteria:
Patients
Healthy volunteers:
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+
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.
Respiration rate measurement accuracy per 60s epoch against visually scored capnography data, recorded on subjects lying down and resting on a bed.
Time frame: 60s
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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