Sleepiz One+ vs. Capnography and Electrocardiography

Not Applicable

Recruiting

• Conditions: COPD; Diabetes; Asthma; Hypertension; Cardiovascular Diseases; Sleep Apnea; Respiratory Disease
• Interventions: Device: Sleepiz One+

• Registration Number: NCT06569940
• Lead Sponsor: Sleepiz AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-18
• Status Verified: 2024-08
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-23
• Last Update Submitted: 2024-08-23
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sleepiz One+ vs. gold standard	Sleepiz One+	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.

Primary Outcome Measures

Name	Time	Method
Instantaneous respiration rate measurement accuracy per 60s epoch	During 60 seconds	Instantaneous respiration rate measurement accuracy per 60s epoch against visually scored capnography data, recorded on subjects lying down and resting on a bed
Instantaneous heart rate measurement accuracy per 60s epoch	During 60 seconds	Instantaneous heart rate measurement accuracy per 60s epoch against ECG R-R interval, recorded on subjects lying down and resting on a bed

Trial Locations

Locations (1)

Schlaflabor Fluntern; 🇨🇭 Zürich, Zurich, Switzerland