Clinical trial NCT04102709: Spire Medical Health Tag Actigraphy and Sleep Validation in Adults
Official title: Spire Medical Health Tag Actigraphy and Sleep Validation in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Lead sponsor: Spire, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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
* 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

Primary outcomes:
measure: Evaluate the performance of the HT's step algorithm at different walking speeds.
timeFrame: One day
measure: Evaluate the performance of the HT's sleep algorithm accuracy in classifying sleep and wake.
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Spire, Inc.
state: California
Study officials:
affiliation: Chief Scientific Officer
name: Neema Moraveji
role: PRINCIPAL_INVESTIGATOR
References: