Validation of Smart Garments for Metabolic Rate Estimation

Healthy Clinical Trial

Official title:

Validation of Myant Skiin Smart Garments for Metabolic Rate Estimation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06026761
• Other study ID #: Myant/Waterloo/44441
• Status: Completed
• Start date: March 28, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: February 2024
• Source: Myant Medical Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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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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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Skiin garment and pods
Participants will be asked to wear two pieces of equipment to record physiological data: A Skiin garment that contains IMU and ECG sensors 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

Locations

Country	Name	City	State
Canada	University of Waterloo - Engineering 7	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Myant Medical Corp.	University of Waterloo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	Heart rate obtained via ECG from the Skiin device	Through study completion (1 hour total), average heart rate calculated every 1 minute
Primary	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
Primary	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	Age	Participant age	During participant inclusion
Secondary	Sex	Participant sex (male, female, other)	During participant inclusion
Secondary	Weight	Participant weight (kg)	During participant inclusion
Secondary	Height	Participant height (cm)	During participant inclusion
Secondary	Fitness Level	Participant self-reported fitness level (sedentary, low, moderate, high, very high)	During participant inclusion