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Not yet recruitingNCT07834983Updated Sep 22, 2026

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

An observational study in Epilepsy, Pediatric Epilepsy and Autonomic Dysfunction, sponsored by Assiut University. Not yet recruiting. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Assiut University · Observational

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Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
60
Ages
1 Year to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 15 studies in Epilepsy by Assiut University — 8 open to participants now, 8 under way, none of them phase 3. Epilepsy · Assiut University.

Planned enrollment
10th of 12
60 · median 92
Started
2026
with 3 others
Observational
12 of 15
7 open now
Registered
14th of 15
by date

Among the 15 studies in Epilepsy by Assiut University, this one is the 10th largest by planned enrollment of the 12 observational ones that give a count, is one of 4 that started in 2026, is one of 12 observational ones, and was the 14th registered.

Epilepsy

1,848 studies on the registry are indexed under Epilepsy; 420 are open to participants now.

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Open to participants now

8 of the 15 studies in Epilepsy by Assiut University are open now. Recruiting first, the newest first:

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All 8 open studies →

Where they have run

Who these studies take

Of the 283 Epilepsy studies recruiting now, 112 (40%) set no upper age limit and 148 (52%) stop at 75 or younger; 140 take children under 18; 55 take healthy volunteers.

This study: 1 Year to 18 Years · all sexes.

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02

Study 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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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).

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2026
First posted
Sep 22, 2026
StartEst.
Oct 2026
Primary completionEst.
Oct 2027
CompletionEst.
Nov 2027
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07834983
Lead sponsor
Assiut University
Responsible party
Taha Muhammad Amin (Resident, Assiut University) — Principal investigator
First posted
Sep 22, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Sep 22, 2026
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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