Spire Medical Health Tag Actigraphy and Sleep Validation in Adults

NCT04102709 | Completed

• 1 other identifier: 2019-05-16
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Health Tag DEVICE

Health Monitoring Device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Spire, Inc.: lead

Study Sites (1)

Spire, Inc.

San Francisco, California, 94110, United States

Location

Study Officials

• Neema Moraveji

  Chief Scientific Officer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: September 25, 2019
• Study Start: August 19, 2019
• Primary Completion: September 18, 2019
• Study Completion: September 18, 2019
• Last Updated: October 29, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)