Spire Medical Health Tag Actigraphy and Sleep Validation in Adults

NCT ID: NCT04102709

Last Updated: 2019-10-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-19
• Study Completion Date: 2019-09-18

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.

Conditions

Healthy Volunteers

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Health Tag

Health Monitoring Device

Intervention Type: DEVICE

Eligibility Criteria

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Spire, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neema Moraveji

Role: PRINCIPAL_INVESTIGATOR

Chief Scientific Officer

Locations

Spire, Inc.

San Francisco, California, United States

Countries

United States

Other Identifiers

2019-05-16

Identifier Type: -

Identifier Source: org_study_id