Risk Factors of SUDEP

NCT03074279 | Unknown DMC

• 1 other identifier: 8601
• Study Type: observational
• Target: 408
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

Epilepsy; SUDEP; case-control study; risks factors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Familial Risk factors for SUDEP

  1 day

• Needs and expectations of bereaved families on epilepsy related death information

  1 day

Study Arms (2)

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

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

Interventions

Interview with a psychologist and self-reported questionnaires OTHER

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

Cases; Controls

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Uhmontpellier

Montpellier, Montpellier, 34295, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 26749016 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Sudden Unexpected Death in Epilepsy

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Marie-Christine Picot, MD, PhD

  University Hospital, Montpellier

  STUDY DIRECTOR

Central Study Contacts

Marie-Christine Picot, MD, PhD

CONTACT

467338978; mc-picot@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 8, 2017
• Study Start: July 1, 2011
• Primary Completion: December 31, 2017
• Study Completion: July 31, 2018
• Last Updated: March 8, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)