Heart Rate Variability (HRV) Analysis in Patients With Nocturnal Epileptic Seizures
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|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
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|Condition or disease|
|Heart Rate Nocturnal Seizures Autonomic Nervous System Epilepsy|
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|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|
|Patients with epilepsy having seizures in sleep|
- 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.
- 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 ]
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|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|
- Clinically firm diagnosis of epilepsy.
- 18 years of age
- Having the capacity to consent to this project.
- Patients who are on medication for cardiac conditions like beta blockers, anti arrhythmic agents, calcium channel blockers.
- Patients who have other neurological disorders which may be associated with an autonomic neuropathy
- Patients who have diabetes, renal failure or another general medical disorder associated with autonomic neuropathy.
- Patients unable to complete self-report measures unaided.
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
|Sheffield Teaching Hospitals NHS Foundation Trust|
|Sheffield, South Yorkshire, United Kingdom, S10 2JF|
|Principal Investigator:||Athi Ponnusamy, MD||Sheffield Teaching Hospitals NHS Foundation Trust|
|Responsible Party:||Sheffield Teaching Hospitals NHS Foundation Trust|
|Other Study ID Numbers:||
|First Posted:||June 12, 2015 Key Record Dates|
|Last Update Posted:||April 9, 2018|
|Last Verified:||April 2018|
Central Nervous System Diseases
Nervous System Diseases