Health Condition 1: 4- Measurement and Monitoring
Conditions
Interventions
Intervention1: NIL: NIL
Sponsors
BraveHeart Wireless Inc BHW
Eligibility
Inclusion criteria
Inclusion criteria: •All subjects shall be at least 18 years or older. •In good general health without any evidence of medical issues and/or problems. •The subject must have the ability to understand and provide written informed consent. •The subject must be willing and able to comply with study procedures and duration. •Male or female of any race but a wide demographic across age, gender and race is preferred. •It is required, by ISO 80601-2-56, that 30% - 50% of subjects shall be recruited that demonstrate as febrile from the population of all subjects identified for the study. •A febrile subject is someone having: â?ª An elevated core temperature of 38.0 Dec C (100.4 Deg F) or higher as measure by the Reference Clinical Thermometer (RCT). â?ª An elevated sublingual temperature of 37.5 Deg C (99.5 Deg F) or higher as measured by the RCT, or â?ª An elevated axillary temperature of 37.2 Deg C (99.0 Deg F) or higher as measured by the RCT.
Exclusion criteria
Exclusion criteria: •The subject is a current smoker •The subject is pregnant, lactating or trying to get pregnant. •The subject has a known history of heart disease, lung disease, kidney or liver disease. •Diagnosis of asthma, sleep apnea, or use of CPAP. •Diagnosed or self-reported respiratory diseases/impairment. •Diagnosed or self-reported cardiovascular diseases/impairment. •Subjects with inflammation at the measuring site. •Subjects that have taken antipyretics in the preceding 120 min. •Subjects meeting contraindications for device •Subjects showing inflammation or skin damage at the measuring site (i.e., if site selection has open wounds, erythema, redness, old scar/wounds) •Subjects with known skin allergies (e.g., silicone or hydrocolloid adhesives and/or hydrogel) •The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study procedures. •The subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Respiration Rate Data collected on the ML Explorer app. â?¢ HR data collected on the ML Explorer App. â?¢ Core body Temperature Data recorded from the reference clinical thermometer (RCT) as noted against the Bravo1 PM Platform skin temperature results. â?¢ Respiration Rate Data collected with the CapnosteamTM20p Portable Bedside Monitor Capnograph. â?¢ Multi-modality bio signals (PPG, temperature, motion) collected with ADI Fenda and SpO2 watches. Timepoint: 1.5 Hours | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Respiration Rate Data collected on the ML Explorer app. â?¢ HR data collected on the ML Explorer App. â?¢ Core body Temperature Data recorded from the reference clinical thermometer (RCT) as noted against the Bravo1 PM Platform skin temperature results. â?¢ Respiration Rate Data collected with the CapnosteamTM20p Portable Bedside Monitor Capnograph. â?¢ Multi-modality bio signals (PPG, temperature, motion) collected with ADI Fenda and SpO2 watches. Timepoint: 1.5 Hours | — |
Countries
India
Contacts
Public ContactDr K Naresh Chandra
Outcome results
None listed