Validation of Smart Garments for Metabolic Rate Estimation

NCT ID: NCT06026761

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-28
• Study Completion Date: 2024-01-01

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

Conditions

Healthy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy individuals

Metabolic study protocol

Skiin garment and pods

Intervention Type: 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

Interventions

Skiin garment and pods

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Waterloo

OTHER

Sponsor Role: collaborator

Myant Medical Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Tung, PhD

Role: PRINCIPAL_INVESTIGATOR

Waterloo University

Locations

University of Waterloo - Engineering 7

Waterloo, Ontario, Canada

Countries

Canada

Other Identifiers

Myant/Waterloo/44441

Identifier Type: -

Identifier Source: org_study_id