Healthy Volunteers
Conditions
Brief summary
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
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.
Interventions
DEVICEHealth Tag
Health Monitoring Device
Sponsors
Spire, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the performance of the HT's step algorithm at different walking speeds. | One day | Accuracy of the Medical Health Tag for the measurement of steps to the Reference |
| Evaluate the performance of the HT's sleep algorithm accuracy in classifying sleep and wake. | One day | Accuracy of the HT for the measurement of 60 seconds sleep epochs and total sleep time |
Countries
United States
Outcome results
None listed