Skip to content

Risk Factors of SUDEP

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03074279
Acronym
PRERIES
Enrollment
408
Registered
2017-03-08
Start date
2011-07-01
Completion date
2018-07-31
Last updated
2017-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Epilepsy, SUDEP, case-control study, risks factors

Brief summary

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.

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.

Interventions

OTHERInterview 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

Sponsors

French Foundation for Epilepsy Research (FFRE)
CollaboratorUNKNOWN
The French League Against Epilepsy (LFCE)
CollaboratorUNKNOWN
University Hospital, Bordeaux
CollaboratorOTHER
University Hospital, Lille
CollaboratorOTHER
Hospices Civils de Lyon
CollaboratorOTHER
University Hospital, Marseille
CollaboratorOTHER
Central Hospital, Nancy, France
CollaboratorOTHER
Paris AP-HP (La Pitié, St Anne, Necker, Robert Debré)
CollaboratorUNKNOWN
Rennes University Hospital
CollaboratorOTHER
University Hospital, Strasbourg, France
CollaboratorOTHER
ToulouseUniversity Hospital
CollaboratorUNKNOWN
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Risk factors for SUDEP1 day* 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

Secondary

MeasureTime frameDescription
Familial Risk factors for SUDEP1 dayFamily history of epilepsy, Family history of sudden death, arrhythmias, sleep apnea
Needs and expectations of bereaved families on epilepsy related death information1 day

Countries

France

Contacts

Primary ContactMarie-Christine Picot, MD, PhD
mc-picot@chu-montpellier.fr467338978

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026