Status:
COMPLETED
Spire Medical Health Tag Actigraphy and Sleep Validation in Adults
Lead Sponsor:
Spire, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-80 years
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 evaluat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 19 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 18 2019
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04102709
Start Date
August 19 2019
End Date
September 18 2019
Last Update
October 29 2019
Active Locations (1)
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1
Spire, Inc.
San Francisco, California, United States, 94110