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Not Yet RecruitingNCT07148934

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
60 (estimated)
Sponsor
University of Turku · Academic / Other
Sex
All
Age
0 Years – 10 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTSmartphone seismographic recording and Bed Based Ballistocardiographic recordingsA short recording of heart rhythm using a smartphone and bed-based ballistocardiogram.

Timeline

Start date
2026-04-01
Primary completion
2026-12-01
Completion
2027-06-01
First posted
2025-08-29
Last updated
2026-04-13

Locations

1 site across 1 country: Finland

Source: ClinicalTrials.gov record NCT07148934. Inclusion in this directory is not an endorsement.