Heart Rate Variability (HRV) Analysis in Patients With Nocturnal Epileptic Seizures

November 14, 2023 updated by: Sheffield Teaching Hospitals NHS Foundation Trust
Epilepsy is disabling and costly to patients and the health service. Nearly 400,000 people in England suffer from epilepsy. About 40% of these patients are known to have seizures predominantly in sleep. All seizures pose risk to the individual both physical and psychological. Nocturnal seizures pose extra risk as the diagnosis may be missed or delayed. Patients with nocturnal seizures are also thought to be at particular risk of sudden unexpected death in epilepsy (SUDEP), especially if their seizures are unobserved. In patients with poor seizure control, the risk of SUDEP has been found to be as high as 9 per 1,000 patient years. Previous studies show that many seizures are associated with changes in the Autonomic Nervous System (ANS) tone. The ANS tone can be assessed using heart rate variability parameters (HRV). A few studies suggest that ANS tone changes tend to precede the onset of epileptic seizure related surface electroencephalographic (EEG) changes, suggesting that ANS tone changes could be used in seizure alarm or intervention systems. This prospective study intends to focus on seizures from sleep and study HRV parameters in the immediate preictal state of the seizure and compare these with resting HRV parameters in the same patient with the aim of finding HRV metrics which could help to identify the presence of seizures in longterm electrocardiographic (ECG) recordings, or help predict seizure occurrence, or provide information about the current risk of seizures. This study will also investigate whether there are differences in the alterations of HRV parameters between different forms of epilepsy and whether seizure lateralisation has an impact on HRV parameters.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
        • Sheffield Teaching Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with epilepsy admitted for three- to five-day diagnostic or pre-surgery video-electro-encephalography and ECG (VT) monitoring in the video telemetry unit at the Royal Hallamshire Hospital in Sheffield will be recruited for the study.

Description

Inclusion Criteria:

  1. Clinically firm diagnosis of epilepsy.
  2. 18 years of age
  3. Having the capacity to consent to this project.

Exclusion Criteria:

  1. Patients who are on medication for cardiac conditions like beta blockers, anti arrhythmic agents, calcium channel blockers.
  2. Patients who have other neurological disorders which may be associated with an autonomic neuropathy
  3. Patients who have diabetes, renal failure or another general medical disorder associated with autonomic neuropathy.
  4. Patients unable to complete self-report measures unaided.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with epilepsy having seizures in sleep

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alterations in heart rate variability (HRV) parameters at baseline (interictal sleep), immediately before (pre-ictal) and during nocturnal epileptic seizures in epilepsy patients.
Time Frame: Alterations in HRV during nocturnal seizures occuring during patients stay in VT unit for 3-5 days

1. Alterations in heart rate variability (HRV) parameters at baseline (interictal sleep), immediately before (pre-ictal) and during nocturnal epileptic seizures. The composite measure consists of the following: Time Domain HRV metrics: SDNN to describe overall variability; RMSSD to describe Parasympathetic component of HRV FrequencyDomain HRV: HF for Parasympathetic, LF for Sympathetic and LF/HF for sympatho vagal balance.

Non-linear HRV metrics: CVI for Parasympathetic and CSI for Sympathetic component.
Alterations in HRV during nocturnal seizures occuring during patients stay in VT unit for 3-5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparing Alterations in the HRV parameters in temporal lobe epileptic seizures from extra temporal lobe epileptic seizures.
Time Frame: Alterations in HRV during nocturnal seizures occuring during patients stay in VT unit for 3-5 days
Alterations in HRV during nocturnal seizures occuring during patients stay in VT unit for 3-5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Investigators

  • Principal Investigator: Athi Ponnusamy, MD, Sheffield Teaching Hospitals NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

June 3, 2015

First Submitted That Met QC Criteria

June 11, 2015

First Posted (Estimated)

June 12, 2015

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STH18174

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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