NCT06874361已完成不适用
A Prospective, Double-blind, Sham-controlled, Randomized Clinical Trial to Assess the Safety and Efficacy of the Mi-Helper Device for Acute Treatment of Migraine in an At Home Setting.
Mi-Helper, Inc.2 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2025年3月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Pain Freedom at 2 Hours Post Treatment
研究概览
简要总结
This is a prospective, double-blind, sham-controlled, randomized, decentralized trial. This study aims to assess the safety and efficacy of the Mi-Helper transnasal cooling device for acute treatment of migraine in an at home setting.
Adults aged 18 years to 70 years old with a diagnosis of migraine (with or without aura) for at least one year will be recruited for this study.
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
- •Age of 18 to 70 years, inclusive, of either sex at birth.
- •Lives in the contiguous United States.
- •Self-reported to be able to read and understand English sufficiently to provide electronic Informed Consent.
- •Diagnosis of migraine with or without aura for at least 1 year.
- •Individual experiences 2 to 8 migraine attacks per month documented via migraine eDiary during screening.
- •Migraine onset before 50 years of age, self-reported during screening.
- •Migraine preventive medication unchanged for 4 weeks prior to study enrollment.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Individuals that own a functioning smartphone device, internet connection (Wi-Fi or data plan) and are willing to download the study app.
排除标准
- •Participant has difficulty distinguishing his or her migraine attacks from other types of headaches such as tension, exertion, cluster, hormonal or sinus headaches.
- •Participant has 15 or more headache days per month reported via migraine eDiary and during screening.
- •Participant using any opioid medication at the time of screening.
- •Participant has received Botox treatment, barbiturates, SPG block, nerve blocks or trigger point injections in the head or neck within the last 4 weeks of screening.
- •Participant lives at an altitude of 2000 meters or more above sea level.
- •Self-reported intolerance to intranasal therapy.
- •Self-reported recurrent epistaxis or chronic rhinosinusitis.
- •Self-reported sinus or intranasal surgery within the last 4 months of screening.
- •Self-reported history of 'complicated migraine or headaches' (i.e., hemiplegic migraine, ophthalmoplegic migraine, migrainous infarction, basilar migraine, post-traumatic headaches, post-concussion syndrome).
- •Known or suspected pregnancy as self-reported by the prospective participant at the time of screening.
- •Prospective participant unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity.
- •Self-reported diagnosis of alcohol or substance abuse disorder at the time of screening.
- •Participant with active chronic pain syndromes, such as fibromyalgia, chronic pelvic pain, or Complex Regional Pain Syndrome (CRPS); or other pain syndrome like trigeminal neuralgia.
- •Participant with severe uncontrolled psychiatric conditions or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments.
- •Failure to adhere to or inability to complete Study App inputs and onboarding activities during the screening period. Participants who are not adherent during the screening period are not eligible for study entry.
- •Participation in a previous clinical study with the Mi-Helper device.
- •Participation in a migraine study or any other interventional clinical study within the3 months prior to screening.
- •Participant has an uncontrolled medical issue at the time of screening.
- •Any condition for which transnasal air flow would be contraindicated, as determined by the Principal Investigator (PI).
研究组 & 干预措施
Group I (active treatment)
Experimental
10 liters per minute of dehumidified air administered via Mi-Helper for 15 minutes
干预措施: Mi-Helper (Device)
Group II (sham)
Sham Comparator
2 LPM of ambient air administered intermittently via Mi-Helper for 15 minutes
干预措施: Mi-Helper (Device)
结局指标
主要结局
Pain Freedom at 2 Hours Post Treatment
时间窗: 2 hours
Proportion of participants with a change in headache severity from mild/moderate/severe pain at baseline to no pain at 2 hours after treatment completion (if rescue medication was not used)
次要结局
- Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post Treatment(2 hours)
- Participants' Global Impression of Acute Treatment Effect(24 Hours)
- Sustained Pain Freedom at 24 Hours Post Treatment(2-24 Hours)
- Pain Relief at 2 Hours Post Treatment(2 hours)
- Participants' global impression of acute treatment effect(24 Hours)
研究者
研究点 (2)
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