HealthyNCT06026761
Validation of Smart Garments for Metabolic Rate Estimation
An observational study of Healthy, run by Myant Medical Corp. at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Skiin garment and pods
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 28 Mar 2023to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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)?
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Myant Skiin Smart Garments for Metabolic Rate Estimation
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.
.
Read the detailed description
- Following consent, the participants will first be asked to fill out a participant information questionnaire.
- 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).
- 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).
- 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.
- 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
- Being tested
- Skiin garment and pods
- Keywords
- wearable, metabolic, MET minute, calories, physical activity, accelerometer, heart rate
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skiin garment and podsDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals | Metabolic study protocol Receives: Device: Skiin garment and pods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate obtained via ECG from the Skiin device
Measured: 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)
Measured: 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
Measured: Through study completion (1 hour total), average activity calculated every 1 minute
Secondary outcomes (5)
Age
Participant age
Measured: During participant inclusion
Sex
Participant sex (male, female, other)
Measured: During participant inclusion
Weight
Participant weight (kg)
Measured: During participant inclusion
Height
Participant height (cm)
Measured: During participant inclusion
Fitness Level
Participant self-reported fitness level (sedentary, low, moderate, high, very high)
Measured: During participant inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start28 Mar 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myant Medical Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Responsible party
- Sponsor
- Investigators
- James Tung, PhD, Principal investigator, Waterloo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026761
- Sponsor's protocol ID
- Myant/Waterloo/44441
- Status last verified
- Feb 2024
- First submitted
- 23 May 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Follow data use agreement policy as outlined by Myant (de-identified data only)
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Myant Skiin Smart Garments for Metabolic Rate Estimation
- ClinicalTrials.gov ID
- NCT06026761
- Acronym / sponsor ID
- Myant/Waterloo/44441
- Conditions
- Healthy
- Keywords
- wearable, metabolic, MET minute, calories, physical activity, accelerometer, heart rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Myant Medical Corp.Industry (pharma, biotech, devices)
- Collaborators
- University of Waterloo
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
Detailed description
- Following consent, the participants will first be asked to fill out a participant information questionnaire.
- 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).
- 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).
- 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.
- Exercise tasks are described in more detail in the attached document. In general, all exercises can be modified by the participant to modulate intensity
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals | – | Device: Skiin garment and podsMetabolic study protocol |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- Healthy male and female adult volunteers (18y - 64y old)
- 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)?
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skiin garment and podsParticipants 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 | Device | Healthy individuals |
Primary outcome
Heart rate
Time frame: Through study completion (1 hour total), average heart rate calculated every 1 minute
Heart rate obtained via ECG from the Skiin device
Metabolic rate
Time frame: Through study completion (1 hour total), average metabolic rate calculated every 1 minute
Metabolic rate obtained via the gold standard portable metabolic cart (COSMED K5)
Acceleration /Activity counts
Time frame: Through study completion (1 hour total), average activity calculated every 1 minute
Epoch-based physical activity counts using accelerometer data obtained through Skiin device
5 secondary outcomes
Age
Time frame: During participant inclusion
Sex
Time frame: During participant inclusion
Weight
Time frame: During participant inclusion
Height
Time frame: During participant inclusion
Fitness Level
Time frame: During participant inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: Undecided. Follow data use agreement policy as outlined by Myant (de-identified data only)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Tung, PhD principal investigator
Waterloo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Myant Medical Corp. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: Through study completion (1 hour total), average heart rate calculated every 1 minute). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.