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Sleepiz One+ vs. Capnography and Electrocardiography

Sleepiz One+ vs. Capnography and Electrocardiography

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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

Study details
    Sleep Apnea
    Asthma
    COPD
    Hypertension
    Diabetes
    Respiratory Disease
    Cardiovascular Diseases

NCT06569940

Sleepiz AG

14 October 2025

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