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NCT07834983

Time-Domain Heart Rate Variability and QT Interval in Children With Epilepsy

Sponsor: Assiut University

View on ClinicalTrials.gov

Summary

Epilepsy is a chronic neurological disorder characterized by recurrent unprovoked seizures, but it can also affect the autonomic nervous system and cardiovascular function. Certain anti-epileptic medications and seizure activity may influence cardiac rhythm, beat-to-beat heart rate variability (HRV), and ventricular repolarization (measured by the QT interval). The primary purpose of this study is to evaluate autonomic tone and cardiac electrical conduction in children with epilepsy receiving anti-epileptic drugs by measuring time-domain HRV and the corrected QT (QTc) interval, comparing patients on monotherapy, patients on polytherapy, and healthy controls. A total of 60 children aged 1 to 18 years will be enrolled across three groups: 20 children with epilepsy receiving single-drug therapy (monotherapy), 20 children with epilepsy receiving two or more medications (polytherapy), and 20 healthy children serving as controls. All participants will complete non-invasive assessments during a single visit, including: * Collection of clinical and demographic data (age, sex, epilepsy duration, and medication details) * A standard 12-lead electrocardiogram (ECG) to measure the QT interval and calculate the QTc using Fridericia's formula * A 5-minute continuous resting ECG recorded in a supine position after 10 minutes of quiet rest to calculate time-domain HRV parameters (SDNN, RMSSD, and pNN50) The findings aim to detect early autonomic or electrophysiological alterations, aiding in the understanding of cardiac safety in pediatric epilepsy management.

Official title: Time-Domain Heart Rate Variability and QT Interval in Children With Epilepsy Receiving Anti-Epileptic Drugs

Key Details

Gender

All

Age Range

1 Year - 18 Years

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2026-10

Completion Date

2027-11

Last Updated

2026-09-22

Healthy Volunteers

Not specified