NCT03200769已完成不适用
Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy
University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2014年7月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Number of patients from group IIa and IIb with decreased seizure frequency
研究概览
简要总结
Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy. The primary goal is to evaluate the efficacity after 3 months of obstructive sleep apnea syndrome treatment by CPAP on the epilepsy seizures frequency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age ≥
- •Patient suffering of pharmacoresistant epilepsy.
- •Frequency of epilepsy crisis : minimum 4 per month.
- •Antiepileptic drug on a stable dose for at least 2 months.
- •SA-SDQ score ≥
- •Written informed consent obtained.
- •Patient affiliated with a social security regimen.
排除标准
- •Pregnant females (female subjects who are lactating are not excluded).
- •Anterior CPAP treatment.
- •Central apnea >20% during the initial polysomnography.
- •Mental retardation or severe cognitive impairment.
- •Presence of pseudo-crisis.
结局指标
主要结局
Number of patients from group IIa and IIb with decreased seizure frequency
时间窗: At 3 months
Decreased \> 50% after CPAP treatment
次要结局
- Cognitive capacity questionnaire (MOCA)(At 3 months ; At 6 months ; At 12 months)
- Impact of the localisation and the type of epilepsy based on patient medical history exam (video-electroencephalogram) on the SAS risk(At 12 months)
- Anxiety and depression questionnaire (BECK)(At 3 months ; At 6 months ; At 12 months)
- Impact of AHI on the number of night seizures(At 12 months)
- Number of seizures based on the seizures diary(At 12 months)
- Somnolence questionnaire (Epworth)(At 3 months ; At 6 months ; At 12 months)
- Number of patients who became drug-susceptible based on the seizures diary(At 3 months ; At 6 months ; At 12 months)
- Quality of life questionnaire (QOLIE 31)(At 3 months ; At 6 months ; At 12 months)
- Number of patients from group IIa and IIb with decreased seizure frequency(At 6 months ; At 12 months)
- Number of patients from group III with decreased seizure frequency(At 3 months ; At 6 months ; At 12 months)
研究者
研究点 (2)
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