Holter Versus Skiin Garments

Completed

• Conditions: Cardiac Arrhythmia

• Registration Number: NCT05983484
• Lead Sponsor: Myant Medical Corp.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-08-01
• Study First Posted: 2023-08-09
• Study Start: 2023-10-16
• Status Verified: 2024-02
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patient's perception	At the end of the study, 1 to 14 days after initiation.	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).

Trial Locations

Locations (1)

Partners in Advanced Cardiac Evaluation (PACE) clinic; 🇨🇦 Newmarket, Ontario, Canada