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OpenTrials
Completed

NCT Number: NCT04102709

Spire Medical Health Tag Actigraphy and Sleep Validation in Adults

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Spire, Inc.

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health Tag

Device

Health Monitoring Device

Primary outcomes

  1. Evaluate the performance of the HT's step algorithm at different walking speeds.

    Time frame: One day

    Accuracy of the Medical Health Tag for the measurement of steps to the Reference

  2. Evaluate the performance of the HT's sleep algorithm accuracy in classifying sleep and wake.

    Time frame: One day

    Accuracy of the HT for the measurement of 60 seconds sleep epochs and total sleep time

Sponsors and collaborators

Lead sponsor

Spire, Inc.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 25, 2019
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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