Spire Medical Health Tag Actigraphy and Sleep Validation in Adults

Healthy Volunteers Clinical Trial

Official title:

Spire Medical Health Tag Actigraphy and Sleep Validation in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04102709
• Other study ID #: 2019-05-16
• Status: Completed
• Start date: August 19, 2019
• Est. completion date: September 18, 2019

Study information

• Verified date: September 2019
• Source: Spire, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 18, 2019
• Est. primary completion date: September 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• Health Tag
Health Monitoring Device

Locations

Country	Name	City	State
United States	Spire, Inc.	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Spire, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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