Ignite Creation Date:
2024-05-06 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03661606
Status:
COMPLETED
Last Update Posted:
2018-10-16
First Post:
2018-09-01
Brief Title:
Biovitals Analytics Engine - Altitude Study
Sponsor:
Biofourmis Singapore Pte Ltd
Organization:
Biofourmis Singapore Pte Ltd
Study Overview
Official Title:
Measuring the Effect of High Altitude Hypoxia on an Individuals Physiology - an Analytical Study to Validate the Performance of the Biovitals Analytics Engine BA Engine - Altitude Study
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Unexpected adverse health events resulting in a hospital admission can be potentially avoided by leveraging novel physiological sensors combined with advanced computational techniques to predict changes in physiology prior to the onset of symptoms In other words significant improvement in the prevention of avoidable hospitalization can be achieved via early detection and actionable insights of clinical deterioration at the individual patient level as they go about their normal day to day activities Physiological changes can be a warning sign that a persons health is deteriorating and as such is an important component of an early detection tool
The Biovitals Analytics Engine BA Engine is intended to be used with data from already validated sensors measuring physiological parameters including heart rate HR respiratory rate RR and activity in ambulatory patients being monitored in a healthcare facility or at home The device provides a continuous output- Biovitals Index BI which indicates whether the relationships among the patients monitored vital signs change from those measured at baseline derived from measurements previously obtained during daily routine activities The BI is based on an integrated computation evaluating changes in the parameters and their relationship to each other
As part of the clinical validation of the BA Engine it is important to first undertake an analytical validation to demonstrate that the BA correctly processes the physiological data for which it is designed and generates an accurate detection of physiological change In order to generate a measurable physiological change subjects will move from sea level to an altitude environment which is known to cause increases in HR and RR
The Biovitals Analytics Engine BA Engine is intended to be used with data from already validated sensors measuring physiological parameters including heart rate HR respiratory rate RR and activity in ambulatory patients being monitored in a healthcare facility or at home The device provides a continuous output- Biovitals Index BI which indicates whether the relationships among the patients monitored vital signs change from those measured at baseline derived from measurements previously obtained during daily routine activities The BI is based on an integrated computation evaluating changes in the parameters and their relationship to each other
As part of the clinical validation of the BA Engine it is important to first undertake an analytical validation to demonstrate that the BA correctly processes the physiological data for which it is designed and generates an accurate detection of physiological change In order to generate a measurable physiological change subjects will move from sea level to an altitude environment which is known to cause increases in HR and RR
Detailed Description:
Subjects will wear one armband linked biosensor the Everion CD to capture their HR RR and activity levels continuously for 4 days
Measurements will be taken at sea level baseline during controlled rest and normal day-to-day activities without exercise for the first 3 days to establish an individuals physiological baseline On Day 4 subjects will be monitored for another period of controlled rest followed by 2 hours in a simulated altitude intervention chamber with an altitude change of 3000 meters At the chamber site the subject will rest quietly for 1 hour outside the chamber prior to entering the chamber for 2 hours In the chamber subjects will be asked to remain seated At the completion of the chamber run subjects will hand back the device and smartphone and complete a user experience survey A follow-up phone call to check on subjects will then be done on day 5 before closing the study
Measurements will be taken at sea level baseline during controlled rest and normal day-to-day activities without exercise for the first 3 days to establish an individuals physiological baseline On Day 4 subjects will be monitored for another period of controlled rest followed by 2 hours in a simulated altitude intervention chamber with an altitude change of 3000 meters At the chamber site the subject will rest quietly for 1 hour outside the chamber prior to entering the chamber for 2 hours In the chamber subjects will be asked to remain seated At the completion of the chamber run subjects will hand back the device and smartphone and complete a user experience survey A follow-up phone call to check on subjects will then be done on day 5 before closing the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None