Spire Medical Health Tag Actigraphy and Sleep Validation in Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

Official Title
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Spire Medical Health Tag Actigraphy and Sleep Validation in Adults

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Device: Health Tag


Participation Criteria
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Eligibility Criteria
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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. those requiring a wheelchair or who are housebound (haven't left their home without assistance in the last week) Sleep disorder Gait issue 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: be on-time for the study be on-time returning the devices the following day avoid alcohol or intoxicants before and during the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Health Tag|Health Monitoring Device|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |