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

NCT07834983 | Not Yet Recruiting

• 1 other identifier: HRV & QT in Pediatric Epilepsy
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Epilepsy; Pediatric Epilepsy; Autonomic Dysfunction; Cardiac Arrhythmias

Keywords

Heart rate variability; HRV; QT interval; QTc; Antiepileptic drugs; Antiseizure medications; Time-domain HRV; SDNN; Electrocardiography; Monotherapy vs polytherapy

Outcome Measures

Primary Outcomes (1)

• Corrected QT Interval (QTc)

  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

Study Arms (3)

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

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.

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.

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Epilepsy; Primary Dysautonomias; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Autonomic Nervous System Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 22, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09