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Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • You are in the age range 20-50 and healthy (as defined by the absence of any of the exclusion criteria below) • You have a BMI between 18 and 25 kg/m2. • You will pass a medical examination consisting of a short physical examination, com-pletion of a questionnaire and a short ECG. • You are willing to accept that the data collected will be stored and processed in en-crypted form, archived for at least 10 years and possible published. • You are willing to wear an optical sensor in the chest area, near the sternum, that is applied on your skin by a technical expert. • You are willing to remove hair (by shaving) at the location of the sensors (area of ~10x5 cm2).
Exclusion criteria
Exclusion criteria: • You smoke. • You are pregnant. • You have drunk alcohol the night before the start of the test day. • You have used recreational drugs in the past 3 months. • You have known cardiovascular disease, chronic anemia, Raynaud's phenomenon, systemic sclerosis, systemic lupus erythematosus, mixed connective tissue disease, vasculitis, rheumatoid disease, or are familiar with psychiatric-and/or neurological dis-orders, • You are claustrophobic and not able to spend an hour in a confined space. • You have given blood in the past 72 hours. • You are overly susceptible to air sickness (form of motion sickness, where one gets sick from air travel). • You are allergic or sensitive to silicon material or patches. • You have been at altitude (>2000m) for more than a week in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is to measure multi-color, multi-distance PPG signals at different SpO2 levels (varied by exposing volunteers to different simulated altitudes). Data will be collected by the developed WOP on the chest and arm and compared with the SpO2 value measured using a commercial wearable optic device (WristOx3150, Nonin Medical Inc, Plymouth USA) on the finger. Algorithms will be developed based on the multi-color, multi-distance raw PPG data of each sensor individually in order to optimize the correlation between the sensor data and measured SpO2 at different simulated heights in all volunteers. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome is to measure multi-color, multi-distance PPG signals for different perfusion levels, induced by PORH. In particular the ratio of blue and green PPG signals is hypothesized to correlate with tissue perfusion [Patent Application P135808EP00, *wearable sensor for microvascular diameter*]. As such, this PPG ratio will be plotted as a function of time, with indications of when the occlusion and reactive hyperaemia phases occurred. In parallel, the local tissue perfusion measured by the Pericam laser speckle contrast imaging is plotted as a function of time, to explore its correlation with the PPG ratio. | — |
Countries
Netherlands