Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache (O214)
Feasibility Study of Normobaric Oxygen Delivered by a High Flow Concentrator in the Treatment of Chronic Headache With or Without Abuse of Painkillers
Chronic headache is most often associated with drug abuse and medication overuse headache (MOH) is the main complication of migraine disease results in chronic daily headache. The first phase of treatment consists of drug withdrawal .
The second phase of treatment (called consolidation) is to maintain the balance: treating headaches and reducing / stopping the drug use.
The aim of this study is
- verify the feasibility of a home withdrawal treatment with normobaric oxygen therapy (NOT) delivery by high flow concentrator
- use normobaric oxygen therapy (NOT) as a therapeutic measure to treat headache through withdrawal period.
It is a feasibility pilot study in chronic headache with or without medication-overuse. All patients receive a care for outpatient withdrawal that involves sudden stop drug abuse and used to be called "traditional management". The subsequent attacks will be treated with NOT from a high-flow concentrator
Primary endpoint. Feasibility study of treatment with NOT evaluated by the percentage of patients who accepted NOT during the withdrawal phase then to treat attacks.
Secondary endpoints. Efficacy will be assessed by the percentage of patients having no chronic headaches two months after the start of withdrawal (less than 15 days of headache per month) and no longer in drug abuse (less than 10 days per month with drug intake).
Visits V1 (first visit) Inclusion V2 at one month V3 at 3 months V4 (last vist) at 6 months
Effective : 30 patients
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Paris、法国、75010
- 招聘中
- Centre d'Urgence des Céphalées, hôpital Lariboisière
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接触：
- Caroline Roos, MD
- 电话号码：00 33 1 49 95 89 53
- 邮箱：caroline.roos@aphp.fr
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副研究员：
- Dominique Valade, MD
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首席研究员：
- Caroline ROOS, MD
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副研究员：
- Cecilia Burcin, MD
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副研究员：
- Jérome MAWET, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Migrainous according to the criteria of the International Headache Society
- Medication-overuse headaches according of the International Headache Society
- No prophylaxis treatment or same prophylaxis treatment from more than one month
- Signed informed consent
Exclusion Criteria:
- Pregnancy
- One or more failed withdrawal treatment
- analgesic treatment for another reason than headache
- Contraindication of normobaric oxygen therapy
- Contraindication of ketoprofen (rescue therapy)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：platinium IRC9LXO2AWQ
Normobaric oxygen therapy with high flow concentrator to treat headaches attacks, 30 minutes of oxygene inhalation with mask, 9l/minute, no frequency limitation
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high flow concentrator delivering normobaric oxygen after extraction, 9 liter per minute dimensions: 46 * 67 * 36 cm
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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percentage of patients accepted the normobaric oxygen treatment during withdrawal and consolidation phases
大体时间：6th month
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6th month
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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number of headache days per month
大体时间：6th month
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6th month
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number of session of oxygen during the 6 months
大体时间：6th month
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6th month
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number of rescue medication taking on the 6 months
大体时间：6th month
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6th month
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Hospital Anxiety and Depression Scale
大体时间：1st month, 2d month and 3rd month
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1st month, 2d month and 3rd month
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Headache Impact Test- 6
大体时间：1st, 2d and 3rd month
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1st, 2d and 3rd month
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Patient Global Impressions of Change Scale
大体时间：1st, 2d, 3rd, 4th, 5th and 6th month
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1st, 2d, 3rd, 4th, 5th and 6th month
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Migraine Disability Assessment Questionnaire Scale
大体时间：3rd and 6th month
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3rd and 6th month
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合作者和调查者
出版物和有用的链接
一般刊物
- Kavuk I, Katsarava Z, Selekler M, Sayar K, Agelink MW, Limmroth V, Diener HC. Clinical features and therapy of medication overuse headache. Eur J Med Res. 2004 Dec 22;9(12):565-9.
- Lanteri-Minet M, Valade D, Geraud G, Chautard MH, Lucas C. Migraine and probable migraine--results of FRAMIG 3, a French nationwide survey carried out according to the 2004 IHS classification. Cephalalgia. 2005 Dec;25(12):1146-58. doi: 10.1111/j.1468-2982.2005.00977.x.
- Evers S, Marziniak M. Clinical features, pathophysiology, and treatment of medication-overuse headache. Lancet Neurol. 2010 Apr;9(4):391-401. doi: 10.1016/S1474-4422(10)70008-9.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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