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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleepiz One+ vs. gold standard | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleepiz One+ | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Instantaneous respiration rate measurement accuracy per 60s epoch | Instantaneous respiration rate measurement accuracy per 60s epoch against visually scored capnography data, recorded on subjects lying down and resting on a bed | During 60 seconds |
| Instantaneous heart rate measurement accuracy per 60s epoch | Instantaneous heart rate measurement accuracy per 60s epoch against ECG R-R interval, recorded on subjects lying down and resting on a bed | During 60 seconds |
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Inclusion Criteria:
Patients:
Healthy volunteers
Exclusion Criteria:
Patients
Healthy volunteers:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marta Stepien, MSc | Contact | +41 44 586 08 88 | marta.stepien@sleepiz.com |
| Name | Affiliation | Role |
|---|---|---|
| Christian Neumann, Dr. med. | Zentrum für Schlafmedizin "Schlaflabor Fluntern" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schlaflabor Fluntern | Recruiting | Zurich | Canton of Zurich | 8044 | Switzerland |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D006973 | Hypertension |
| D003920 | Diabetes Mellitus |
| D012120 | Respiration Disorders |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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Annotators of capnography data were blinded to the values provided by the investigational device
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| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |