Sleepiz One+ Versus Capnography and Electrocardiography

Overview

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.

Full Title of Study: “Single-center Evaluation of Sleepiz One+ in Measuring Respiration Rate and Heart Rate Compared to Gold Standard”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Other
  • Masking: None (Open Label)
• Study Primary Completion Date: March 31, 2023

Interventions

• 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.

Arms, Groups and Cohorts

• Other: Sleepiz One+ vs. gold standard
  • 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.

Clinical Trial Outcome Measures

Primary Measures

• 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

Participating in This Clinical Trial

Inclusion Criteria

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 Criteria:

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Sleepiz AG
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Contact(s)
  • Marta Stepien, +41 0 44 586 08 88, marta.stepien@sleepiz.com