Biovitals Analytics Engine - Altitude Study
Anahtar kelimeler
Öz
Açıklama
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.
Tarih
| Son Doğrulandı: | 09/30/2018 |
| İlk Gönderilen: | 08/31/2018 |
| Tahmini Kayıt Gönderildi: | 09/04/2018 |
| İlk Gönderilen: | 09/06/2018 |
| Son Güncelleme Gönderildi: | 10/13/2018 |
| Son Güncelleme Gönderildi: | 10/15/2018 |
| Fiili Çalışma Başlangıç Tarihi: | 07/29/2018 |
| Tahmini Birincil Tamamlanma Tarihi: | 09/29/2018 |
| Tahmini Çalışma Tamamlanma Tarihi: | 10/03/2018 |
Durum veya hastalık
Müdahale / tedavi
Other: Monitoring arm
Evre
Kol Grupları
| Kol | Müdahale / tedavi |
|---|---|
| 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. |
Uygunluk kriterleri
| Çalışmaya Uygun Yaşlar | 18 Years İçin 18 Years |
| Çalışmaya Uygun Cinsiyetler | All |
| Sağlıklı Gönüllüleri Kabul Ediyor | Evet |
| Kriterler | 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 |
Sonuç
Birincil Sonuç Ölçütleri
1. Analytical validation testing of the BA Engine's output [Changes in subjects physiology at an altitude of 3000m compared to baseline physiology]
