Comparing Sleepiz One+ with Capnography and ECG for monitoring vital signs
Single-center Evaluation of Sleepiz One+ Algorithm in Estimating Respiration Rate and Heart Rate Compared to Gold Standard
This study is testing if a new device called Sleepiz One+ can measure breathing and heart rates more accurately than traditional methods in both healthy adults and patients with chronic conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sleepiz AG Industry-sponsored |
| Locations | 1 site (Zurich, Canton of Zurich) |
| Trial ID | NCT06569940 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of the Sleepiz One+ algorithms in measuring respiratory rate (RR) and heart rate (HR) against traditional methods such as end-tidal carbon dioxide measurement (EtCO2) Capnography and electrocardiography (ECG). It will involve both healthy adults and patients with chronic conditions like hypertension, COPD, asthma, and diabetes, assessing their vital signs at rest in a clinical setting. The goal is to determine which method provides more accurate and reliable data for monitoring these vital signs, which are crucial for managing chronic diseases.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with one or more chronic medical conditions or healthy volunteers without any diagnosed chronic conditions.
Not a fit: Patients with cardiac pacemakers or other implanted electrical devices, as well as pregnant or breastfeeding women, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the monitoring of vital signs, leading to better management of chronic diseases and improved patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving vital sign monitoring, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zurich, Canton of Zurich
- Schlaflabor Fluntern — Zurich, Canton of Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Christian Neumann, Dr. med. — Zentrum für Schlafmedizin "Schlaflabor Fluntern"
- Study coordinator: Marta Stepien, MSc
- Email: marta.stepien@sleepiz.com
- Phone: +41 44 586 08 88
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.