NCT05712226

Sleepiz One+ Versus Capnography and Electrocardiography

Single-center Evaluation of Sleepiz One+ in Measuring Respiration Rate and Heart Rate Compared to Gold Standard

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Sleepiz AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• COPD
• Hypertension
• Sleep Apnea
• Asthma
• Heart Diseases
• Respiratory Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-02-22
• Primary completion: 2023-04-06
• Completion: 2023-04-06
• First posted: 2023-02-03
• Last updated: 2023-05-08

Locations

1 site across 1 country: Switzerland