Clinical trial NCT06026761: Validation of Smart Garments for Metabolic Rate Estimation
Official title: Validation of Myant Skiin Smart Garments for Metabolic Rate Estimation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: wearable
metabolic
MET minute
calories
physical activity
accelerometer
heart rate
Lead sponsor: Myant Medical Corp.
Sponsor class: INDUSTRY
Collaborators: name: University of Waterloo
First posted: 2023-09-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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Detailed description: 1. Following consent, the participants will first be asked to fill out a participant information questionnaire.
2. Equipment setup - SKIIN: For the SKIIN garments, participants will use the elastic research belt for the study. The belt is an fabric, elastic strap that has been washed and sanitized to be worn over the skin at the chest or waist. A private area for changing will be provided. The SKIIN sensor pod will be attached to the holster on the belt to collect inertial measurement unit (IMU) data and electrocardiography (ECG) data similar to the motion and cardiac sensors in many wrist-worn activity tracking systems (e.g., Apple Watch). The electrodes must be in contact with the skin to acquire ECG data. Data from the Skiin garments will be acquired using the custom research interface provided by the supplier. The data is acquired wirelessly and stored on the local computer (and no data is sent to the cloud).
3. Equipment setup - K5 COSMED: For the reference/criterion- standard metabolic measurement system, a wearable indirect calorimetry system will be used. This system comprises of a mask fitted over the mouth and nose connected to a portable device that analyzes breath gas composition and volume. The mask has been cleaned and sanitized prior to use with a participant. The data is acquired on the device and stored on a local computer (no data is sent to the cloud).
4. Once the equipment has been set up for the participant, an overview of the activities and exercise tasks to be conducted during the protocol will be demonstrated.
5. Exercise tasks are described in more detail in the attached document. In general, all exercises can be modified by the participant to modulate intensity

Eligibility criteria: Inclusion Criteria:

- 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)?

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Heart rate
timeFrame: Through study completion (1 hour total), average heart rate calculated every 1 minute
measure: Metabolic rate
timeFrame: Through study completion (1 hour total), average metabolic rate calculated every 1 minute
measure: Acceleration /Activity counts
timeFrame: Through study completion (1 hour total), average activity calculated every 1 minute
Secondary outcomes:
measure: Age
timeFrame: During participant inclusion
measure: Sex
timeFrame: During participant inclusion
measure: Weight
timeFrame: During participant inclusion
measure: Height
timeFrame: During participant inclusion
measure: Fitness Level
timeFrame: During participant inclusion
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo - Engineering 7
state: Ontario
Study officials:
affiliation: Waterloo University
name: James Tung, PhD
role: PRINCIPAL_INVESTIGATOR
References: