Biovitals Analytics Engine - Altitude Study

Launched by BIOFOURMIS SINGAPORE PTE LTD. · Sep 5, 2018

Keywords

ClinConnect Summary

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 chambe...

Gender

ALL

Eligibility criteria

• 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