RecruitingNot ApplicableNCT06569940

Sleepiz One+ vs. Capnography and Electrocardiography

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

Sponsor

Sleepiz AG

Enrollment

35 participants

Start Date

Jul 18, 2024

Study Type

INTERVENTIONAL

Conditions

Cardiovascular Diseases Hypertension Asthma COPD Diabetes Sleep Apnea Respiratory Disease

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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 Criteria11

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

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 42 minutes.