Holter Versus Skiin Garments

Study Overview
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Brief Summary
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The goal of this observational study is to compare the electrocardiogram recording from Holter monitor with textile sensors (in the form of clothing) in patients diagnosed with arrhythmia. The study aims to answer the following questions: Can the textile sensors provide continuous monitoring and detect arrhythmias? Do patients prefer to wear textile sensors instead of the Holter? Participants that need Holter monitoring as part of their standard care will be invited to participate in the study. They will simultaneously wear both, the Holter monitor and the textile sensors for the time prescribed by their physician. Participants will also be asked to answer a questionnaire in the initial assessment and at the end of the study.

Official Title
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Non-Invasive Monitoring of Arrhythmias Electrocardiogram (ECG) Using Textile Sensors (MYANT)

Conditions
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Cardiac Arrhythmia

Intervention / Treatment
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* Device: Skiin Underwear


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being addressed to the PACE cardiology clinic to perform an ECG due to a diagnosed or suspected cardiovascular disease. Age above 18 Understand and speak English enough to consent and answer the study questionnaire. A medical need for Holter monitoring, and having a personal smartphone (iOS or Android), compatible with the Skiin app (application used to monitor the patient using the wearable device) Exclusion Criteria: Pregnancy Implanted defibrillator or pacemaker Absence of garment fitting the participant's body Open wound or dressing (e.g. band-aid) on a body part that needs to be in contact with the Skiin electrodes Severe frailty such that donning or doffing the garment may cause a danger of fall. Sensitive skin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Skiin Underwear|All participants enrolled will wear simultaneously the PocketECG (Standard Holter) and the Skiin Underwear Chestband (wearable textile). Each participant will wear both systems for the duration prescribed by their physician (1 to 14 days).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Usable ECG | The duration of diagnostic ECG from PocketECG minus the duration of diagnostic ECG from Skiin underwear | Throughout the entire data collection period, that is between 1 and 14 days | 
| Difference in Heart Rate | The heart rate obtained from PocketECG minus the heart rate obtained from Skiin underwear | Throughout the entire data collection period, that is between 1 and 14 days | 
| Difference in RR intervals | The RR intervals obtained from PocketECG minus the RR intervals obtained from Skiin underwear | Throughout the entire data collection period, that is between 1 and 14 days | 
| Arrhythmic events | The number and proportion of arrhythmic events obtained by PocketECG and by Skiin underwear | Throughout the entire data collection period, that is between 1 and 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's perception | A questionnaire developed by Myant containing 10 questions related to the comfort, usability, ease of use and enjoyment will be applied to assess patients' perception of the Skiin underwear and of the PocketECG and to compare both systems, with answers on a 7 point Lickert Scale (from Strongly disagree to Strongly Agree, no numeric scoring). | At the end of the study, 1 to 14 days after initiation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECG, Wearable, Holter