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NCT Number: NCT07834983

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

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.

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 1 and 18 years
  • Confirmed diagnosis of epilepsy according to International League Against Epilepsy (ILAE) criteria (for epileptic cohorts)
  • Receiving anti-epileptic medication for 3 months or more (for epileptic cohorts)
  • Healthy children matched by age and sex (for control cohort)

Exclusion criteria

  • Age younger than 1 year or older than 18 years
  • Structural heart disease
  • Chronic systemic illness
  • Acute illness at the time of study evaluation
  • Concurrent use of medications known to affect cardiac conduction or autonomic tone

Treatment and study plan

Primary outcomes

  1. Corrected QT Interval (QTc)

    Time frame: Baseline

    Corrected QT interval (reported in milliseconds) measured from a standard 12-lead ECG recorded at standard velocity and amplitude. The QT interval is measured in lead V5 (or lead II if lead V5 is unsuitable) across three consecutive cardiac cycles and averaged. QTc is calculated using Fridericia's formula: QTc = QT / RR^(1/3).

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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