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The purpose of this study is to collect data to validate the step- (actigraphy) and sleep-tracking performance of the Medical Health Tag device developed by Spire Health.
The purpose of this study is to collect data to validate the step- (actigraphy) and sleep-tracking performance of the Medical Health Tag device developed by Spire Health. The step data will be evaluated in a controlled environment over a range of approximately 1.0-2.5 miles per hour (i.e., slow to moderate walking) via Reference manual counting and pedometer. The sleep data will be evaluated in a natural environment (i.e., the participant's daily life and home) over one afternoon and night with Reference sleep/wake data.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Tag | Device | Health Monitoring Device |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the performance of the HT's step algorithm at different walking speeds. | Accuracy of the Medical Health Tag for the measurement of steps to the Reference | One day |
| Evaluate the performance of the HT's sleep algorithm accuracy in classifying sleep and wake. | Accuracy of the HT for the measurement of 60 seconds sleep epochs and total sleep time | One day |
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Inclusion Criteria:
Subject must have the ability to understand and provide written informed consent Subject is over 18 years of age Subject must be willing and able to comply with study procedures and duration Subject is a non-smoker Male or female of any race
Exclusion Criteria:
Subject is considered as being morbidly obese (defined as BMI >39.5)
Any medical condition that may prevent successful completion of the tasks in a healthy manner.
Subjects with known respiratory conditions such as severe asthma, flu, bronchitis, or shortness of breath.
Subjects with self-reported heart or cardiovascular conditions such as congestive heart failure (CHF) or history of stroke or heart attack.
Any neurological condition such as Parkinson's, Alzheimer's, and Epilepsy
Subjects experiencing significant sleep impairment or sleep disturbances
Those with insufficient English language skills to either fully evaluate their understanding of these exclusion criteria during screening or that would otherwise impair their ability to fully participate
Pregnant at the time of the study
Unwilling to commit, in writing, to:
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The subject selection will be a mix of males and females with diverse physiques. Healthy individuals 18 years or older, from the general population will be recruited for participation. The subjects must understand the study and consent to participate by signing the Informed Consent Form. The subjects must be healthy showing no evidence of medical problems as indicated by satisfactorily completing the health assessment form. Eligible subjects need to meet all of the inclusion criteria and none of the exclusion criteria for participation.
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| Name | Affiliation | Role |
|---|---|---|
| Neema Moraveji | Chief Scientific Officer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spire, Inc. | San Francisco | California | 94110 | United States |
To be determined.
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