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OpenTrials
Completed

NCT Number: NCT05983484

Holter Versus Skiin Garments

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.

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Key information

Conditions

Cardiac Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Partners in Advanced Cardiac Evaluation (PACE) clinic

Newmarket, Ontario, L3Y 2P6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skiin Underwear

Device

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).

Other names: PocketECG

Primary outcomes

  1. Difference in Usable ECG

    Time frame: 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

  2. Difference in Heart Rate

    Time frame: 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

  3. Difference in RR intervals

    Time frame: 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

  4. Arrhythmic events

    Time frame: 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 outcomes

  1. Patient's perception

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Myant Medical Corp.

Industry

Collaborators

  • Partners in Advanced Cardiac Evaluation

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 9, 2023
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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