Biovitals Analytics Engine - Altitude Study

Measuring the Effect of High Altitude (Hypoxia) on an Individual's Physiology - an Analytical Study to Validate the Performance of the Biovitals™ Analytics Engine (BA Engine - Altitude Study)

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 person's 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Simulated Altitude Chamber

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 individual's 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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 538945
    • Singapore Aeromedical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 50 Male or female, voluntary adults aged between ≥ 18 to ≤ 65 years
• Ability to read and understand basic English Language
• Women who are of childbearing potential, must if sexually active, agree to use appropriate contraceptive measures for the duration of the study
• Able to perform all activities in the study procedure

Exclusion Criteria:

• High altitude residents (>500m)
• Anemic
• Athlete
• Lung, airways and/or sinus pathology
• Previous myocardial infarction or coronary revascularization (PCI or CABG)
• Any prior history of heart failure
• Any prior history of moderate or severe valvular heart disease
• Any history of pulmonary disease (asthma, emphysema/ COPD, pulmonary hypertension)
• Any other medical condition or functional problems (e.g. previous intolerance or current contraindication to altitude, unable to exercise, skin problems, schizophrenia and bipolar disorder) that in the judgment of the investigator will impair the subjects ability to complete the processes needed in the clinical study
• Unable or unwillingness to sign the informed consent
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Monitoring arm; Subjects will wear one armband linked biosensor: the Everion® CD, to capture their HR, RR and activity levels, continuously for 4 days.

Other: Simulated Altitude Chamber; 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 individual's 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 altitude change of 3000 meters. At the chamber site, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analytical validation testing of the BA Engine's output	This study aims to demonstrate that the BA Engine correctly processes monitored physiological data to generate accurate, reliable and precise detection of changes in an individual's physiology at high altitude (3000m) when compared to their baseline physiology at sea-level, as per its design specifications and to meet its intended use.	Changes in subjects physiology at an altitude of 3000m compared to baseline physiology

Collaborators and Investigators

• Sponsor: Biofourmis Singapore Pte Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2018
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): October 4, 2018

Study Registration Dates

• First Submitted: September 1, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 14, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PIEC/2018/013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No