Validation of Smart Garments for Metabolic Rate Estimation

NCT06026761 | Completed

• 1 other identifier: Myant/Waterloo/44441
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to assess the use of Myant Skiin garments for the purpose of estimating metabolic rate in 20 adult (18-64 yrs) healthy participants. The main question it aims to answer is What is the accuracy of metabolic rate estimate from the Skiin algorithm utilizing Skiin data, as compared to observation and a gold-standard sensor? Participants will be asked to perform a number of scripted tasks and their data will be assessed and compared against gold standard wearable indirect calorimetry device (COSMED K5) measurements. .

Conditions

Healthy

Keywords

wearable; metabolic; MET minute; calories; physical activity; accelerometer; heart rate

Outcome Measures

Primary Outcomes (3)

• Heart rate

  Heart rate obtained via ECG from the Skiin device

  Through study completion (1 hour total), average heart rate calculated every 1 minute

• Metabolic rate

  Metabolic rate obtained via the gold standard portable metabolic cart (COSMED K5)

  Through study completion (1 hour total), average metabolic rate calculated every 1 minute

• Acceleration /Activity counts

  Epoch-based physical activity counts using accelerometer data obtained through Skiin device

  Through study completion (1 hour total), average activity calculated every 1 minute

Secondary Outcomes (5)

• Age

  During participant inclusion

• Sex

  During participant inclusion

• Weight

  During participant inclusion

• Height

  During participant inclusion

• Fitness Level

  During participant inclusion

Study Arms (1)

Healthy individuals

Metabolic study protocol

Device: Skiin garment and pods

Interventions

Skiin garment and pods DEVICE

Participants will be asked to wear two pieces of equipment to record physiological data: 1. A Skiin garment that contains IMU and ECG sensors 2. A Cosmed K5 metabolic cart that will record breathing rate data Participants will then be asked to perform various tasks of daily living (e.g. watching TV, sweeping the floor), general strength exercises (e.g. squats, triceps dips, lunges), and aerobic exercises (e.g. walking, running) as instructed by researchers

Healthy individuals

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

20 (18-64 yrs) healthy participants will be recruited as a convenience sample to validate the proposed methods. An n=20 was chosen to permit a breadth of personal characteristics regarding gait patterns and balance control behaviour.

You may qualify if:

• \- Healthy male and female adult volunteers (18y - 64y old)
• must answer No to the following:
• Have you had musculoskeletal and/or neurological foot, ankle, knee, or hip conditions, such as stroke, arthritis, trauma, joint surgery?
• Have you been diagnosed with a neurological disorder or cognitive impairment such as Alzheimer's disease, migraine, epilepsy, dementia, Parkinson's disease, brain tumors, multiple sclerosis?
• Have you experienced a diagnosed concussion or brain trauma in the past 6 months?
• Do you have a condition that limits your capacity for aerobic exercise (e.g., asthma, cardiac condition)?

You may not qualify if:

• individuals with (self-reported) lower limb conditions, neurological disorders, history of concussion/brain trauma, and/or condition limiting exercise is to mitigate additional risk for injury and/or adverse reactions associated with exercise activities.

Sponsors & Collaborators

• Myant Medical Corp.: lead
• University of Waterloo: collaborator

Study Sites (1)

University of Waterloo - Engineering 7

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• James Tung, PhD

  Waterloo University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: September 7, 2023
• Study Start: March 28, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

CA (1)