Spire Medical Health Tag Actigraphy and Sleep Validation in Adults

Spire

Status: Completed

Conditions: Healthy Volunteers

Treatments: Device: Health Tag

Study type: Observational

Funder types: Industry

Identifiers

NCT04102709

2019-05-16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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