Migraine Headache Mitigation Utilizing Avulux Color Filtering Lenses
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Reduction in migraine frequency
研究概览
简要总结
This will be a randomized double blind cross over interventional trial to determine if Avulux lenses are able to reduce headache symptoms in patients
详细描述
Participants:
This study will include a total of 40 participants aged 18 and over who have been screened for migraine headache history. Patients who attended the SBC Headache class with a diagnosis of Migraine from the last 12 months will be selected and assigned a number. Random number set will be used to select the 40 patients. Additional 40 patients will be selected to meet the total initial enrollment of 40 patients in the end. These 40 patients will be randomly assigned to Avulux or Control groups. Each patient will be assigned a unique identifier, and the rest of the correspondents will not use patient demographics.
Design:
The study will be a randomized, double blind, crossover interventional trial. Participants will be randomly assigned to one of 2 groups of 20. 1. Experimental Group: Participants in this group will wear Avulux lenses during the testing sessions. 2. Control Group: Participants in this group will wear placebo lenses that resemble Avulux lenses but do not have the same optical properties.
Procedure:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Neither the participants or the researchers will know which treatment is being received during the trial. This will be achieved by using identical looking placebos for control and ensuring all aspects of the treatment administration and assessment are indistinguishable.
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient population: Individuals must have an existing diagnosis code of G43.1 (migraine w aura) or G
- •10 (migraine w aura, not intractable).
- •Only Kaiser Permanente members receiving care at the Fontana Medical Service Areas will be in consideration.
- •Patients that are >18
- •There will no restrictions based on biological sex.
- •Participants will be referred to optical by provider (Neurologists/Optometrist/Primary Care physician).
- •Participants must agree to not initiate any new medical management during the trial or be willing to voluntarily withdrawal from participating in the trial
排除标准
- •Patients who do not have a migraine diagnosis code in their medical record.
- •Patients that have started a new migraine medication within last 30 days
- •Non-Members of Kaiser Permanente
结局指标
主要结局
Reduction in migraine frequency
时间窗: 6 months
headache days per month documented in a headache diary.
Reduction in migraine severity
时间窗: 6 months
Severity of headaches on a scale from no, mild, moderate, and sever pain
次要结局
- Improve quality of life(6 months)
- Medication Use(6 months)