Holter Versus Skiin Garments

• Sponsor: Myant Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05983484
• Collaborator: Partners in Advanced Cardiac Evaluation (Other)
• Enrollment: 50
• Anticipated Duration (Months): 4

Study Details

Study Description

Brief Summary

The goal of this observational study is to compare the electrocardiogram recording from Holter with textile sensors (in the form of clothing) in patients diagnosed with arrhythmia.

The main questions it aims to answer are:

• 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 to simultaneously wear 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrhythmia	Device: Skiin Underwear

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Non-Invasive Monitoring of Arrhythmias Electrocardiogram (ECG) Using Textile Sensors (MYANT)
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Myant Inc.
• Partners in Advanced Cardiac Evaluation

Investigators

• Principal Investigator: Yaariv Khaykin, MD, Partners in Advanced Cardiac Evaluation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Myant Inc.
• ClinicalTrials.gov Identifier: NCT05983484
• Other Study ID Numbers: MYANT/PACE - 073-1819-7
• First Posted: Aug 9, 2023
• Last Update Posted: Aug 9, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Myant Inc.: ECG; Wearable; Holter
• Additional relevant MeSH terms: Arrhythmias, Cardiac

Study Results

No Results Posted as of Aug 9, 2023