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

Sponsor
Assiut University
Study ID
NCT07834983
Status
Not Yet Recruiting

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Conditions

  • Autonomic Dysfunction
  • Cardiac Arrhythmias
  • Epilepsy
  • Pediatric Epilepsy

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Sep 22, 2026
Start date
Oct 31, 2026
Status verified
Sep 2026
Primary completion
Oct 31, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Group I: Monotherapy
    Children aged 1 to 18 years diagnosed with epilepsy according to International League Against Epilepsy (ILAE) criteria who have been receiving a single anti-epileptic medication for at least 3 months. Participants undergo a standard 12-lead ECG for corrected QT interval (QTc) calculation and a 5-minute short-term resting ECG in the supine position for time-domain heart rate variability (HRV) assessment
  • Arm: Group II: Polytherapy
    Children aged 1 to 18 years diagnosed with epilepsy according to International League Against Epilepsy (ILAE) criteria who have been receiving two or more anti-epileptic medications for at least 3 months. Participants undergo a standard 12-lead ECG for corrected QT interval (QTc) calculation and a 5-minute short-term resting ECG in the supine position for time-domain heart rate variability (HRV) assessment.
  • Arm: Group III: Healthy Controls
    Age- and sex-matched healthy children aged 1 to 18 years without a diagnosis of epilepsy, structural heart disease, acute concurrent illness, or chronic systemic disorders. Participants undergo identical evaluation, including a standard 12-lead ECG for QTc calculation and a 5-minute short-term resting ECG in the supine position for time-domain HRV assessment.

Primary Outcome Measure

Corrected QT Interval (QTc) [ Time Frame: Baseline ]

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