Biovitals Analytics Engine - Altitude Study
Condition: Healthy
Study type: Interventional

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 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.
    

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.
    

Intervention name(s): Simulated Altitude Chamber
Intervention type(s): Other
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science