Time-Domain Heart Rate Variability and QT Interval in Children With Epilepsy
Time-Domain Heart Rate Variability and QT Interval in Children With Epilepsy Receiving Anti-Epileptic Drugs
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.
Aperçu de l'étude
Statut
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Eligible children aged 1 to 18 years presenting to the Pediatric Neurology Department at Assiut University Children's Hospital, Assiut, Egypt. The population comprises pediatric patients with a confirmed diagnosis of epilepsy according to ILAE criteria maintained on anti-epileptic monotherapy or polytherapy for at least 3 months, alongside age- and sex-matched healthy controls.
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: CASE_CONTROL
- Perspectives temporelles: CROSS_SECTIONAL
Cohortes et interventions
Groupe / Cohorte |
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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 |
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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. |
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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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Corrected QT Interval (QTc)
Délai: Baseline
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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). |
Baseline
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HRV & QT in Pediatric Epilepsy
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