Nasal Cavity Cooling for the Symptomatic Relief of Migraine Headache - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Reduction of headache
研究概览
简要总结
The aim of the study is to evaluate the effect of self-administered intranasal cooling for the symptomatic relief of migraine headache and associated symptoms in an "at home setting".
10-20 patients - who have been diagnosed according to the International Classification of Headache disorders (2nd Edition) criteria for Episodic migraine, with or without aura - will be included in the study.
During a screening period of one month participants will record their migraine symptoms, any treatment and treatment effects. After a minimum om two migraine attacks the participants receive individual instructions on how to use the The RhinoChill® system. During the following treatment period of the study, participants are instructed to treat their upcoming three migraine attacks with 10 minutes of nasal cavity cooling according to the instructions and thereby register symptoms and treatment effects after 10 minutes, 1 hour, 2 hours, 24 hours and 48 hours.
详细描述
Mechanical techniques to alleviate migraine symptoms have been used for many years, cooling and compression being the most frequently applied. Cryotherapy is the most common non-pharmacological self-administered pain-relieving method currently used by migraine sufferers.
The RhinoChill® System is a CE-Marked device that is currently commercially available in Europe. The RhinoChill® device is intended for temperature reduction in patients via the nasal cavity and can be used across a range of medical and surgical indications where reduction in patient temperature is required. The RhinoChill® system was originally designed specifically for use in the pre-hospital, in-hospital, in-clinic or other clinical settings for the induction of therapeutic hypothermia (reduction in brain and body temperature to between 32-34oC), in which other commercial cooling systems are not practical for use. The RhinoChill® system is portable and runs on batteries. The system cools by spraying an evaporative coolant into the nasal cavity via intranasal catheters. A previous study has shown that the use of RhinoChill® intranasal cooling within a clinic environment provided a statistically significant reduction of pain and associated symptoms of migraine at 5 and 10 minutes (during treatment) and at 1 and 2 hours following treatment along with significant effect on pain and symptoms at 24 hours (all p values <0.001).
The aim of the study is to evaluate the effect of intranasal cooling for the symptomatic relief of migraine headache and associated symptoms when the treatment is self-administered by the patient at home.
The proposed study will be single group assignment with treatment self-administered by patients in their own home, with support and oversight from research support staff working under the direction of the investigators.
The study process is as summarized:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meets the International Classification of Headache Disorders (2nd edition) criteria for episodic migraine, with or without aura.
- •Migraine diagnosis >1 year
- •Migraine attacks 2-8 times/month
- •Living in Malmö-Lund area
- •Reliable contraception (fertile women)
排除标准
- •Any change of migraine prophylaxis within three months prior to study begin
- •Failure of participant to adhere to protocol requirements
- •Smoker or smoker in participants household
- •Prior nose surgery or intranasal obstruction
- •Pregnancy, breast feeding or planned pregnancy during trial period
- •Oxygen dependency
- •Medical history of skull base fracture or severe facial trauma
- •No migraine attacks during prolonged screening phase (60 days)
结局指标
主要结局
Reduction of headache
时间窗: 10 minutes after baseline (immediately after treatment) compared to baseline
Scoring of headache on a 4-graded scale (none-mild-moderate-severe).
Reduction of nausea
时间窗: 10 minutes after baseline (immediately after treatment) compared to baseline
Scoring of symptoms on a 4-graded scale (none-mild-moderate-severe) regarding nausea
Reduction of photophobia
时间窗: 10 minutes after baseline (immediately after treatment) compared to baseline
Scoring of symptoms on a 4-graded scale (none-mild-moderate-severe) regarding photophobia
Reduction of phonophobia
时间窗: 10 minutes after baseline (immediately after treatment) compared to baseline
Scoring of symptoms on a 4-graded scale (none-mild-moderate-severe) regarding photophonia
次要结局
- Headache response(Comparing baseline/before treatment and 1. immediately following treatment (10 minutes),2. 1 hour, 3. 2 hours and 4. 24 hours following treatment.)
- Relapse incidence(Between 2-48 hours after intervention)
- Sustained pain freedom, number of patients that sustain pain freedom 2-48 hours after intervention.(2-48 hours after intervention)
- Impact on nausea(At baseline and 1, 2, 24 hours after treatment)
- Impact on photophobia(At baseline and 1, 2, 24 hours after treatment)
- Impact on phonophobia(At baseline and 1, 2, 24 hours after treatment)
- Comparison of headache response between RhinoChill compared to standard treatment during screening period(Screening phase compared to intervention phase)
- Average headache pain relief(At baseline and 10 minutes, 1, 2 and 24 hours after treatment.)
- Tolerance to rhinochill cooling - pain(10 minutes-1 hour)
- Tolerance to rhinochill cooling - discomfort(10 minutes-1 hour)
- Adverse events(through study completion, an approximated average of 3 months.)