Intranasal Evaporative COOLing for the Symptomatic Relief of Migraine HEADache - A Randomized, Double Blind, Placebo Controlled Study"
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 27
- 试验地点
- 6
- 主要终点
- Pain free at two hours following treatment
研究概览
简要总结
This study will be a randomised placebo controlled trial examining the effectiveness of using an intranasal cooling device (the RhinoChill) in providing relief of pain and symptoms of acute migraine. It will involve using two nasal catheters to cool the nasal cavity which provides localised cooling of the local nasal tissue and the blood vessels which supply blood to the brain. This cooling effect will cause the blood vessels to constrict as well as stimulating special cold receptors that are thought to be involved in the relief of migraine, thereby providing both pain and associated symptomatic relief. Ninety patients will be randomised in a 1:1 fashion, clustered to three different recruitment sites. The patients will have a 30 day period of data collection for their current migraine frequency, treatment and response to medication (with a minimum of 2 migraine attacks recorded) before starting the treatment phase with the RhinoChill Device. Treatment will be for 2 migraine attacks. Only a single treatment is allowed for the first attack, but on the second attack the patient may deliver 2 treatments with a gap of at least 2 hours between treatments.
详细描述
This study is a multi centre, double blinded, randomized, prospective, parallel placebo controlled trial for demonstrating the effectiveness of the RhinoChill System for the symptomatic relief of migraine headache.
The specific study design consists of:
- Participant identification from neurology clinic records and gaining initial consent to transfer contact details to the trial team.
- Telephone contact or direct clinic contact with potential participants to describe the COOLHEAD 2 trial and to seek expressions of interest.
- Initial meetings with potential participants and discussion of trial, provision of patient information leaflets. Informed Consent taking.
- Initial 30 day prospective data collection period (minimum of 2 migraine attacks, longer period if needed)
- Randomisation to either placebo or active RhinoChill
- Device Delivery and training session for the use of the RhinoChill device, self administration, and record keeping.
- Treatment period for the treatment of 2 separate migraines with the RhinoChill.
During an initial screening visit or phonecall, the trial will be discussed with the potential participant and the inclusion/exclusion checklist will be completed.
If the patient meets all inclusion criteria and none of the exclusion criteria, they will be asked for permission to pass on contact details to a member of the trial team for further contact.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •18 Years or over and ≤70 years of age.
- •Migraine diagnosis of at least 1 year.
- •Migraine attacks between 1 and 15 per month.
- •Onset of first migraine < 50 years of age.
- •Migraine prophylaxis medication unchanged for 3 months prior to enrollment
- •Meets International Classification for Headache Disorders (2nd Edition) criteria for diagnosis of Episodic Migraine with or without aura
- •Able to attend and understand a short training session on the practical use of the RhinoChill device and agrees to only use the device as instructed and as laid out in the official instructions for use.
排除标准
- •< 18 and >70 years of age
- •Known oxygen dependency to maintain SaO2 >95%
- •Diagnosed Hypertensive and currently uncontrolled with Systolic BP > 140mmHg and Diastolic BP > 90mmHg on baseline assessment.
- •Marked nasal septal deviation, recurrent epistaxis or chronic Rhino-Sinusitis
- •Intranasal obstruction preventing full insertion of nasal catheter
- •Known acute base of skull fracture or facial trauma
- •Concurrent sinus/intranasal surgery
- •Diagnosed with thromobocytopenia.
- •Previous Stroke or Myocardial Infarction
- •Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity
- •Previously enrolled into the COOLHEAD 1 trial
- •No recorded migraine following initial 30 day data collection period
结局指标
主要结局
Pain free at two hours following treatment
时间窗: Two hours following treatment
Percentage of patients who are pain free two hours following treatment
次要结局
- Headache response(10 mins, 1 hour, 24 hours)
- Relapse Incidence(Between 2 and 48 hours after the intervention)
- Percentage of patients pain free(10 mins, 1 hour, 2 hours, 24 hours)
- Pain response(10 mins, 1 hour, 2 hours, 24 hours)
- Total Migraine Freedom(Between 1 and 24 hours after the intervention)
- Percentage of patients taking rescue medication at 2 hours after treatment(2 hours after treatment)
- Global Impression of Change(to be completed at the end of trial period, an average of 8-10 weeks)
- Global impact on quality of life(to be completed at the end of trial period, an average of 12 weeks)
- Sustained Pain Freedom(Between 1 and 24 hours after the intervention)
- Change in Headache Intensity during treatment.(5 mins and 10 mins)
- Change in Headache Intensity 2 hours following treatment(2 hours following treatment.)
- Time to meaningful relief(Between 10 mins and 24 hours after the intervention)
- Migraine pain scores, pre intervention data collection period versus treatment with the intervention.(to be completed at the end of trial period, an average of 12 weeks)
- Time to freedom from pain(Between 10 mins and 24 hours after the intervention)
- Global impact on disability.(to be completed at the end of trial period, an average of 12 weeks)
- Impact on migraine associated symptoms(To be measured at 10 mins, 1 hour, 2 hours, 24 hours)
- Comparison of symptoms scores between pre intervention data collection period and treatment with the intervention.(to be completed at the end of trial period, an average of 12 weeks)
- Adverse events(From day one of the intervention period until 48 hours post 2nd trial treatment)