Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569940
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Sleepiz One vs Capnography and Electrocardiography
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Single-center Evaluation of Sleepiz One Algorithm in Estimating Respiration Rate and Heart Rate Compared to Gold Standard
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Respiratory Rate RR and heart rate HR are vital signs crucial for assessing a patients 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 eg 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
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 eg 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None