Validity and Algorithm Development for Detection of Supraventricular Tachycardia in Children-A Clinical Pilot Study

Not yet recruiting

• Conditions: Supraventricular Tachycardia; Atrial Fibrillation (AF)

• Registration Number: NCT07148934
• Lead Sponsor: University of Turku

Brief Summary

The aim of this study is to evaluate the reliability of smartphone seismocardiography (SCG) and bed-based ballistocardiography (BCG) for detecting supraventricular tachycardia (SVT) in children aged 0-10 years. The performance of these methods will be compared to the gold standard of continuous telemetry ECG recording.

Detailed Description

This study aims to validate the use of a cardiac monitoring system, comprising a smartphone for seismocardiography (SCG) and a smart mattress for ballistocardiography (BCG), to detect supraventricular tachycardia (SVT) in children aged 0-10 years. Additionally, the study will compare heart rate and breathing rate measurements from these investigational devices against a Philips Intellivue X2 ECG Monitor, which serves as the gold standard. A convenience sample of up to 60 children (30 in the SVT group and 30 in the control group) will be recruited, and their parents will also be interviewed to explore their perceptions of arrhythmia monitoring. The primary objective is to develop and understand algorithms for differentiating SVT from sinus rhythm using SCG and BCG signals.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-22
• Study First Submitted QC: 2025-08-22
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-08-29
• Last Update Posted: 2025-09-05
• Study Start: 2025-12-15
• Primary Completion: 2026-12-15
• Study Completion: 2027-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• For children in Study(SVT) group:

  1. received informed consent from both parents/guardians
  2. the child is treated in the Pediatric wards of Tyks Lighthouse hospital
  3. the child is between the age of 0-10 years
  4. the child has diagnosed or suspected SVT.

• For children in control group:

  1. received informed consent from both parents/guardians
  2. the child is treated in the Pediatric wards of Tyks Lighthouse hospital
  3. the child is between the age of 0-10 years
  4. child has not diagnosed with SVT

Exclusion Criteria

• All participant groups:

  1. not reaching the inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Algorithm development for Seismocardiograph and Ballistocardiograph for detecting Supraventricular tachycardia	2025-2027	Understanding and developing the algorithm to differentiate the supraventricular tachycardia (SVT) and sinus rhythm subjects based on seismocardiography and ballistocardiography signals.

Trial Locations

Locations (1)

University of Turku; 🇫🇮 Turku, Finland