Risk Factors of SUDEP
キーワード
概要
説明
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.
日付
| 最終確認済み: | 02/28/2017 |
| 最初に提出された: | 03/02/2017 |
| 提出された推定登録数: | 03/02/2017 |
| 最初の投稿: | 03/07/2017 |
| 最終更新が送信されました: | 03/02/2017 |
| 最終更新日: | 03/07/2017 |
| 実際の研究開始日: | 06/30/2011 |
| 一次完了予定日: | 12/30/2017 |
| 研究完了予定日: | 07/30/2018 |
状態または病気
介入/治療
Other: Interview with a psychologist and self-reported questionnaires
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Cases Patient with epilepsy who died as a result of confirmed or probable SUDEP and NEAR SUDEP during the study period. | |
| Controls Patient with epilepsy matched by: âge, etiology and type of epilepsy, level of seizure control |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| サンプリング方法 | Non-Probability Sample |
| 健康なボランティアを受け入れる | はい |
| 基準 | 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 |
結果
主な結果の測定
1. Risk factors for SUDEP [1 day]
二次的な結果の測定
1. Familial Risk factors for SUDEP [1 day]
2. Needs and expectations of bereaved families on epilepsy related death information [1 day]
