A Transnasal Evaporative Cooling Device for Acute Treatment of Migraine
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- CoolTech LLC
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Tolerability of the CoolStat Device
研究概览
简要总结
This is a prospective, double-blind, sham-controlled, randomized study to assess the safety, tolerability, and optimal dose of the COOLSTAT Transnasal Thermal Regulating Device for acute treatment of migraine. The hypothesis is that evaporative cooling induced by the CoolStat using only ambient, dry air will reduce the pain and other symptoms of migraine headaches during an acute migraine episode.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the International Classification of Headache Disorders (ICHD-3) diagnostic criteria for migraine with or without aura, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, ophthalmoplegic migraine, migrainous infarction).
- •Patient is between 18 and 80 years of age.
- •Patient experiences 2 to 8 migraine attacks per month.
- •Patient is in good reported general health, with no fever (<38.3C/101F).
- •Patient has had diagnosis of migraine with or without aura over at least 1 year.
- •Migraine onset before 50 years of age.
- •Migraine prophylaxis medication unchanged for 6 weeks prior to study enrollment.
- •Able to attend treatment session within 6 hours of migraine onset, with 48 hours of pain freedom prior to onset of migraine attack.
- •Migraine pain severity of Grade 2 or Grade 3 on day of treatment.
- •Provision of signed and dated informed consent form.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
排除标准
- •has difficulty distinguishing his or her migraine attacks from tension-type headaches
- •Patient has uncontrolled hypertension.
- •Patient has a fever (≥38.3C / 101F).
- •Patient has used opioid medication or barbiturates in the past month.
- •Patient has Medication Overuse Headache (MOH), New Daily Persistent Headache (NDPH) or Chronic Tension Type Headache (CTTH).
- •Patient has 15 or more headache days per month.
- •Patient has used acute treatment(s) for migraine in the 48 hours preceding treatment i.e. over-the-counter (OTC) medications, prescription medications, or medical device).
- •Patient has received Botox treatment, supraorbital or occipital nerve blocks in the last 4 weeks.
- •Intolerance to intranasal neurostimulation or sensory processing disorder that makes the treatment not applicable.
- •Recurrent epistaxis or chronic rhinosinusitis.
- •Recent facial trauma, sinus or intranasal surgery within the last 4 months.
- •Known or suspected pregnancy.
- •Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity.
结局指标
主要结局
Tolerability of the CoolStat Device
时间窗: 15 minutes
Number of subjects who fail to complete the full treatment session
Pain Relief
时间窗: 2 hours
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 2 hours after the CoolStat treatment session.
Safety of the CoolStat Device
时间窗: 24 hours
Number of participants with device-related adverse events
次要结局
- Pain Relief(24 hours)
- Pain Freedom(24 hours)
- Relief From Migraine-associated Symptoms(2 hours)
- Freedom From Migraine-associated Symptoms(2 hours)
- Use of Rescue Medication(0 to 24 hours)