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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
Switzerland
Schlaflabor Fluntern
RECRUITING
Zurich
Contact Information
Primary
Marta Stepien, MSc
marta.stepien@sleepiz.com
+41 44 586 08 88
Time Frame
Start Date: 2024-07-18
Estimated Completion Date: 2024-09-30
Participants
Target number of participants: 35
Treatments
Other: Sleepiz One+ vs. gold standard
Each enrolled participant will undergo a simultaneous recording with the Sleepiz One+, Capnography device and cardiorespiratory polygraphy to measure respiration rate at and heart rate at rest, while sitting and lying down on a bed.
Sponsors
Leads: Sleepiz AG

This content was sourced from clinicaltrials.gov