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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: Health Tag

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 Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Spire, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The subject selection will be a mix of males and females with diverse physiques. Healthy individuals 18 years or older, from the general population will be recruited for participation. The subjects must understand the study and consent to participate by signing the Informed Consent Form. The subjects must be healthy showing no evidence of medical problems as indicated by satisfactorily completing the health assessment form. Eligible subjects need to meet all of the inclusion criteria and none of the exclusion criteria for participation.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Spire, Inc.
• Investigators: Principal Investigator: Neema Moraveji, Chief Scientific Officer

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2019
• Primary Completion (Actual): September 18, 2019
• Study Completion (Actual): September 18, 2019

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): October 29, 2019
• Last Update Submitted That Met QC Criteria: October 28, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2019-05-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: To be determined.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No