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Study not being pursued
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| Name | Class |
|---|---|
| Clinimark, LLC | OTHER |
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The purpose of this study is to clinically validate noninvasive in-ear sensor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal, Healthy Subjects |
| ||
| Induced Febrile Subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-Ear Sensor | Device | The device will passively monitor participants' biometrics |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biometric | Biometric data collected from in-ear sensor device and compared to validated reference device | 1-2 months |
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Inclusion Criteria:
Exclusion Criteria:
Subject is considered as being morbidly obese (defined as BMI >39.5)
Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
Females who are pregnant, who are trying to get pregnant or who have a urine test positive for pregnancy on the day of the study (For Induced Febrile Subjects only)
Subjects with known respiratory conditions such as:
Subjects with self-reported heart or cardiovascular conditions such as:
Self-reported health conditions as identified in the Health Assessment Form
Subjects with medical inflammatory conditions/taking antiinflammation medications
Other known health condition, should be considered upon disclosure in health assessment form
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The study will involve healthy participants 18-50 years of age.
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| Name | Affiliation | Role |
|---|---|---|
| Arthur Cabrera, MD | Clinimark, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinimark | Louisville | Colorado | 80027 | United States |
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