We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469844
Recruitment Status : Unknown
Verified April 2018 by Sheffield Teaching Hospitals NHS Foundation Trust.
Recruitment status was:  Active, not recruiting
First Posted : June 12, 2015
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease
Heart Rate Nocturnal Seizures Autonomic Nervous System Epilepsy

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Heart Rate Variability (HRV) Analysis in Patients With Nocturnal Epileptic Seizures
Study Start Date : October 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Patients with epilepsy having seizures in sleep


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469844


Locations
Layout table for location information
United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
Layout table for investigator information
Principal Investigator: Athi Ponnusamy, MD Sheffield Teaching Hospitals NHS Foundation Trust
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02469844    
Other Study ID Numbers: STH18174
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy
Seizures
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations