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

NCT ID: NCT02469844

Last Updated: 2023-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Rate Nocturnal Seizures Autonomic Nervous System Epilepsy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with epilepsy having seizures in sleep

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Athi Ponnusamy, MD

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS Foundation Trust

Locations

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Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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Ponnusamy A, Marques JL, Reuber M. Heart rate variability measures as biomarkers in patients with psychogenic nonepileptic seizures: potential and limitations. Epilepsy Behav. 2011 Dec;22(4):685-91. doi: 10.1016/j.yebeh.2011.08.020. Epub 2011 Oct 4.

Reference Type BACKGROUND
PMID: 21975299 (View on PubMed)

Ponnusamy A, Marques JL, Reuber M. Comparison of heart rate variability parameters during complex partial seizures and psychogenic nonepileptic seizures. Epilepsia. 2012 Aug;53(8):1314-21. doi: 10.1111/j.1528-1167.2012.03518.x. Epub 2012 May 29.

Reference Type BACKGROUND
PMID: 22642646 (View on PubMed)

Other Identifiers

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STH18174

Identifier Type: -

Identifier Source: org_study_id

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