Spire Medical Health Tag Actigraphy and Sleep Validation in Adults

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT04102709
• Lead Sponsor: Spire, Inc.

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.

Study Timeline

• Study First Submitted: 2019-07-24
• Study Start: 2019-08-19
• Status Verified: 2019-09
• Primary Completion: 2019-09-18
• Study Completion: 2019-09-18
• Study First Submitted QC: 2019-09-23
• Study First Posted: 2019-09-25
• Last Update Submitted: 2019-10-28
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Spire, Inc.; 🇺🇸 San Francisco, California, United States