Sleepiz One+ Versus Capnography and Electrocardiography

Study Overview
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Brief Summary
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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.

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

Conditions
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COPD, Hypertension, Sleep Apnea, Asthma, Heart Diseases, Respiratory Disease

Intervention / Treatment
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* Device: Sleepiz One+


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sleepiz One+ vs. gold standard<br>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. | Device: Sleepiz One+<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiration rate measurement accuracy per 60s epoch against visually scored capnography data, recorded on subjects lying down and resting on a bed. |  | 60s |