NCT06569940

Sleepiz One+ vs. Capnography and Electrocardiography

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Sleepiz AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Respiratory Rate (RR) and heart rate (HR) are vital signs crucial for assessing a patient's overall health, providing insights into various conditions and stressors. Effective management of chronic diseases relies on detecting pathological changes early, with RR being among the most sensitive predictors of patient deterioration. Therefore, vigilant monitoring of RR and HR is vital for improving patient outcomes. The primary aim of this study is to provide a thorough comparison of the performance of Sleepiz One+ algorithms and end-tidal carbon dioxide measurement (EtCO2) Capnography for measuring respiration rate and electrocardiography (ECG) for measuring heart rate, in healthy adults and patients suffering from chronic conditions (e.g., hypertension, Chronic Obstructive Pulmonary Disease (COPD), asthma, diabetes), at rest in a clinical setting when the data is acquired with the new hardware version. Additionally, the investigators will evaluate the performance of RR estimation against the thoracic effort belt and the HR against the pulse oximetry.

Conditions

• Sleep Apnea
• Asthma
• COPD
• Hypertension
• Diabetes
• Respiratory Disease
• Cardiovascular Diseases

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 42 minutes.

Timeline

• Start date: 2024-07-18
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2024-08-26
• Last updated: 2024-08-26

Locations

1 site across 1 country: Switzerland