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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Patients with epilepsy having seizures in sleep

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sheffield Teaching Hospitals NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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