Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-01-08 @ 1:44 AM
Study NCT ID:
NCT06026761
Status:
COMPLETED
Last Update Posted:
2024-02-15
First Post:
2023-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Smart Garments for Metabolic Rate Estimation
Sponsor:
Myant Medical Corp.
Organization:
Study Overview
Official Title:
Validation of Myant Skiin Smart Garments for Metabolic Rate Estimation
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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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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:
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: