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

NCT ID: NCT07148934

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2027-06-15

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.

Conditions

Supraventricular Tachycardia; Atrial Fibrillation (AF)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Study( SVT) Group

Children aged 0-10 years treated in the pediatric wards of Tyks Lighthouse Hospital with diagnosed or suspected supraventricular tachycardia (SVT).

Smartphone seismographic recording and Bed Based Ballistocardiographic recordings

Intervention Type: DIAGNOSTIC_TEST

A short recording of heart rhythm using a smartphone and bed-based ballistocardiogram.

Control Group

Children aged 0-10 years treated in the pediatric wards of Tyks Lighthouse hospital who have not been diagnosed with SVT (i.e., have a normal sinus rhythm).

Smartphone seismographic recording and Bed Based Ballistocardiographic recordings

Intervention Type: DIAGNOSTIC_TEST

A short recording of heart rhythm using a smartphone and bed-based ballistocardiogram.

Interventions

Smartphone seismographic recording and Bed Based Ballistocardiographic recordings

A short recording of heart rhythm using a smartphone and bed-based ballistocardiogram.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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:

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turku

OTHER

Sponsor Role: lead

Responsible Party

Anna Axelin

Professor, Head of Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Turku

Turku, , Finland

Countries

Finland

Facility Contacts

AJDAR ULLAH

Role: primary

ajulla@utu.fi

(+358)404776970

susanna Likitalo

Role: backup

susanna.m.likitalo@utu.fi

Other Identifiers

FIMEA/2025/002511-2

Identifier Type: -

Identifier Source: org_study_id