Biovitals Analytics Engine - Altitude Study
Raktažodžiai
Santrauka
apibūdinimas
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.
Datos
| Paskutinį kartą patikrinta: | 09/30/2018 |
| Pirmasis pateikimas: | 08/31/2018 |
| Numatytas registravimas pateiktas: | 09/04/2018 |
| Pirmas paskelbtas: | 09/06/2018 |
| Paskutinis atnaujinimas pateiktas: | 10/13/2018 |
| Paskutinis atnaujinimas paskelbtas: | 10/15/2018 |
| Faktinė studijų pradžios data: | 07/29/2018 |
| Numatoma pirminio užbaigimo data: | 09/29/2018 |
| Numatoma studijų užbaigimo data: | 10/03/2018 |
Būklė ar liga
Intervencija / gydymas
Other: Monitoring arm
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| 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: Monitoring arm 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. |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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 |
Rezultatas
Pirminės rezultatų priemonės
1. Analytical validation testing of the BA Engine's output [Changes in subjects physiology at an altitude of 3000m compared to baseline physiology]
