Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2026-04-09 @ 12:39 PM
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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2023-05-23', 'studyFirstSubmitQcDate': '2023-08-30', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': 'Through study completion (1 hour total), average heart rate calculated every 1 minute', 'description': 'Heart rate obtained via ECG from the Skiin device'}, {'measure': 'Metabolic rate', 'timeFrame': 'Through study completion (1 hour total), average metabolic rate calculated every 1 minute', 'description': 'Metabolic rate obtained via the gold standard portable metabolic cart (COSMED K5)'}, {'measure': 'Acceleration /Activity counts', 'timeFrame': 'Through study completion (1 hour total), average activity calculated every 1 minute', 'description': 'Epoch-based physical activity counts using accelerometer data obtained through Skiin device'}], 'secondaryOutcomes': [{'measure': 'Age', 'timeFrame': 'During participant inclusion', 'description': 'Participant age'}, {'measure': 'Sex', 'timeFrame': 'During participant inclusion', 'description': 'Participant sex (male, female, other)'}, {'measure': 'Weight', 'timeFrame': 'During participant inclusion', 'description': 'Participant weight (kg)'}, {'measure': 'Height', 'timeFrame': 'During participant inclusion', 'description': 'Participant height (cm)'}, {'measure': 'Fitness Level', 'timeFrame': 'During participant inclusion', 'description': 'Participant self-reported fitness level (sedentary, low, moderate, high, very high)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['wearable', 'metabolic', 'MET minute', 'calories', 'physical activity', 'accelerometer', 'heart rate'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': '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?\n\nParticipants 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.\n\n.', 'detailedDescription': '1. Following consent, the participants will first be asked to fill out a participant information questionnaire.\n2. 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).\n3. 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).\n4. 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.\n5. Exercise tasks are described in more detail in the attached document. In general, all exercises can be modified by the participant to modulate intensity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- Healthy male and female adult volunteers (18y - 64y old)\n\nmust answer No to the following:\n\n* Have you had musculoskeletal and/or neurological foot, ankle, knee, or hip conditions, such as stroke, arthritis, trauma, joint surgery?\n* 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?\n* Have you experienced a diagnosed concussion or brain trauma in the past 6 months?\n* Do you have a condition that limits your capacity for aerobic exercise (e.g., asthma, cardiac condition)?\n\nExclusion Criteria:\n\n* 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."}, 'identificationModule': {'nctId': 'NCT06026761', 'briefTitle': 'Validation of Smart Garments for Metabolic Rate Estimation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Myant Medical Corp.'}, 'officialTitle': 'Validation of Myant Skiin Smart Garments for Metabolic Rate Estimation', 'orgStudyIdInfo': {'id': 'Myant/Waterloo/44441'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy individuals', 'description': 'Metabolic study protocol', 'interventionNames': ['Device: Skiin garment and pods']}], 'interventions': [{'name': 'Skiin garment and pods', 'type': 'DEVICE', 'description': 'Participants will be asked to wear two pieces of equipment to record physiological data:\n\n1. A Skiin garment that contains IMU and ECG sensors\n2. A Cosmed K5 metabolic cart that will record breathing rate data\n\nParticipants 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', 'armGroupLabels': ['Healthy individuals']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N2L 3G1', 'city': 'Waterloo', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Waterloo - Engineering 7', 'geoPoint': {'lat': 43.4668, 'lon': -80.51639}}], 'overallOfficials': [{'name': 'James Tung, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Waterloo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Follow data use agreement policy as outlined by Myant (de-identified data only)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Myant Medical Corp.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Waterloo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}