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NCT05712226 | Completed | COPD


Sleepiz One+ Versus Capnography and Electrocardiography
Sponsor:

Sleepiz AG

Brief Summary:

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.

Condition or disease

COPD

Hypertension

Sleep Apnea

Asthma

Heart Diseases

Respiratory Disease

Intervention/treatment

Sleepiz One+

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 36 participants
Masking: None (Open Label)
Masking Description: Annotators of capnography data were blinded to the values provided by the investigational device
Primary Purpose: Other
Official Title: Single-center Evaluation of Sleepiz One+ in Measuring Respiration Rate and Heart Rate Compared to Gold Standard
Actual Study Start Date : February 22, 2023
Estimated Primary Completion Date : April 6, 2023
Estimated Study Completion Date : April 6, 2023
Arm Intervention/treatment

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.

Device: Sleepiz One+

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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

Sleepiz One+ Versus Capnography and Electrocardiography

Location Details


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Sleepiz One+ Versus Capnography and Electrocardiography

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Switzerland, Zurich

Schlaflabor Fluntern

Zürich, Zurich, Switzerland, 8044

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