Risk Factors of SUDEP (PRERIES)

Risk Factors in Sudden Unexpected Death in Epilepsy of the Adults and Children: A Matched Case-control Study

Numerous studies over the past decade have shown without any doubt that there is a higher mortality risk in patients with epilepsy than in the general population. The cause of death may be related to the cause of epilepsy, being directly related to a seizure (status epilepticus or sudden unexpected death in epilepsy; SUDEP), a consequence of seizures (accidents, etc), other associated pathologies (cancer, cardiovascular disease, ischemic heart disease, pneumonia, etc) or an associated disorder (depression or suicide). A SUDEP is defined as a sudden, non-traumatic, unexpected death in a patient with epilepsy, not necessarily in the presence of witnesses, that is not due to drowning, with or without evidence of a seizure, excluding documented status epilepticus and in which a post-mortem autopsy reveals no anatomical or toxicological cause of death. Little is known about SUDEP and its mechanisms and risk factors.

This epidemiological study is based on the RSME. The Main objective of this study to identify risk factors of SUDEP, in particular night-time supervision and the risks associated with anti-epileptic drugs including compliance and drug interactions.

Study Overview

• Status: Unknown
• Conditions: Epilepsy
• Intervention / Treatment: Other: Interview with a psychologist and self-reported questionnaires

Detailed Description

Numerous studies over the past decade have shown without any doubt that there is a higher mortality risk in patients with epilepsy than in the general population. The cause of death may be related to the cause of epilepsy, being directly related to a seizure (status epilepticus or sudden unexpected death in epilepsy; SUDEP), a consequence of seizures (accidents, etc), other associated pathologies (cancer, cardiovascular disease, ischemic heart disease, pneumonia, etc) or an associated disorder (depression or suicide). A SUDEP is defined as a sudden, non-traumatic, unexpected death in a patient with epilepsy, not necessarily in the presence of witnesses, that is not due to drowning, with or without evidence of a seizure, excluding documented status epilepticus and in which a post-mortem autopsy reveals no anatomical or toxicological cause of death. Little is known about SUDEP and its mechanisms and risk factors.

A French national network on epilepsy related death (Reseau Sentinelle Mortalité Epilepsie, RSME) will be initially established in 2010 by the French League Against Epilepsy (LFCE) under the leadership of bereaved families and supported by the French Foundation for Epilepsy Research (FFRE). This epidemiological study is based on the RSME.

The Main objective of this study to identify risk factors of SUDEP, in particular night-time supervision and the risks associated with anti-epileptic drugs including compliance and drug interactions.

The study design is an epidemiological case-control study. The cases are SUDEP identified in the RSME and French centres of Epileptology.

Epilepsy-related deaths are reported by physicians but also by bereaved families. An interview with a psychologist will be proposed at this moment.

The control group will include patients with epilepsy and relatives of patients from tertiary epilepsy units (in particular, participants of GRENAT registry or a national multicenter study RESPOMSE), private neurologists or general practitioners and thanks from patients associations.

Sociodemographic data, lifestyle, personal and family medical history will be collected during an interview with a psychologist by phone or during a face to face interview. For bereaved families, information on causes and circumstances of beloved one's death will be collected during these interviews.The characteristics of epilepsy will be completed by the patient's neurologist.

• Study Type: Observational
• Enrollment (Anticipated): 408

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Uhmontpellier
    • Contact: Marie Christine Picot, MD, phD; Phone Number: 33 467338978; Email: mc-picot@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cases : Confirmed or probable SUDEP or nearSUDEP reported by physicians of the "Réseau Sentinelle Mortalité Epilepsie" (RSME) or by bereaved families. The bereaved families will be contacted by a psychologist who proposes an interview.

Controls : Patients with epilepsy and relatives of patients recruited from tertiary epilepsy units, private neurologists or general practitioners and thanks from patients associations.

Description

Inclusion Criteria:

Cases : Any patient with active epilepsy (treated or not) or in remission under treatment or without treatment for at least two years who died as a result of confirmed or probable SUDEP or NEAR SUDEP during the study period.

Controls : Patient with active epilepsy (treated or not) or in remission under treatment or without treatment for at least two years and matched by: age, epileptic syndrom and level of seizure controls

Exclusion Criteria:

For cases and controls :patient not living in France, refusal of participation

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; Patient with epilepsy who died as a result of confirmed or probable SUDEP and NEAR SUDEP during the study period.	Other: Interview with a psychologist and self-reported questionnaires; The family members or patients who decide to participate in the study will be asked to complete an interview with a psychologist (semistructured interview, standard form, questionnaires) and self-reported questionnaires
Controls; Patient with epilepsy matched by: âge, etiology and type of epilepsy, level of seizure control	Other: Interview with a psychologist and self-reported questionnaires; The family members or patients who decide to participate in the study will be asked to complete an interview with a psychologist (semistructured interview, standard form, questionnaires) and self-reported questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors for SUDEP	Lifestyle (night-time supervision ...), habits (alcohol consumption ...); Personal cardiac history (arrhythmias, ECG abnormalities ...), respiratory, sleep apnoea, muscular or neurological disorders, mental retardation, associated psychiatric disorders…; Antiepileptic drugs	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Familial Risk factors for SUDEP	Family history of epilepsy, Family history of sudden death, arrhythmias, sleep apnea	1 day
Needs and expectations of bereaved families on epilepsy related death information		1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Hospices Civils de Lyon; University Hospital, Strasbourg, France; Central Hospital, Nancy, France; University Hospital, Bordeaux; Rennes University Hospital; University Hospital, Lille; University Hospital, Marseille; French Foundation for Epilepsy Research (FFRE); The French League Against Epilepsy (LFCE); Paris AP-HP (La Pitié, St Anne, Necker, Robert Debré); ToulouseUniversity Hospital
• Investigators: Study Director: Marie-Christine Picot, MD, PhD, University Hospital, Montpellier

Publications and helpful links

General Publications

• Donner EJ, Waddell B, Osland K, Leach JP, Duncan S, Nashef L, Picot MC. After sudden unexpected death in epilepsy: Lessons learned and the road forward. Epilepsia. 2016 Jan;57 Suppl 1:46-53. doi: 10.1111/epi.13235.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2011
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): July 31, 2018

Study Registration Dates

• First Submitted: March 3, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): March 8, 2017
• Last Update Submitted That Met QC Criteria: March 3, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Epilepsy; risks factors; case-control study; SUDEP
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 8601 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No