Sleepiz One+ vs. Capnography and Electrocardiography

Sleepiz

Status: Enrolling

Conditions: Hypertension; Asthma; Diabetes; Respiratory Disease; Cardiovascular Diseases; Sleep Apnea; COPD

Treatments: Device: Sleepiz One+

Study type: Interventional

Funder types: Industry

Identifiers

NCT06569940

24-001-CI

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Sleepiz One+ vs. gold standard

Other group

Description:

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.

Treatment:

Device: Sleepiz One+