Clinical validation of the efficacy of Sleepaxa eyewear in the preventive treatment of common migraine.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Assessment of changes in the frequency of migraine headaches by using migraine diary/headache diary.
研究概览
简要总结
Sleepaxa Migraine Glasses are specialized eyewear designed to alleviate symptoms associated with migraines and light sensitivity. These glasses incorporate advanced FL-41 tint technology and blue-block technology to provide comprehensive protection against harmful light wavelengths. The FL-41 tint, a mild rose tint, has been scientifically proven to reduce light sensitivity and photophobia by filtering out specific wavelengths of light, particularly in the blue-green spectrum (480-520 nm), which are known to exacerbate migraine symptoms. By reducing the amount of light that reaches the visual cortex, these glasses help in soothing and mitigating migraine symptoms, providing significant relief to sufferers. Blue-block technology in Sleepaxa Migraine Glasses is specifically designed to block high-energy visible (HEV) blue light. The glasses effectively filter out wavelengths in the range of 400-450 nm, which are associated with digital eye strain and can trigger migraines. This technology helps in preventing over-stimulation of the retinal cells, thereby reducing the risk of migraine onset and easing existing symptoms. Given the debilitating nature of migraines and the limitations of current treatment options, there is a clear need for innovative and effective non-pharmacological interventions. Sleepaxa Migraine Glasses offer a promising solution by addressing the photophobia and light sensitivity that often accompany migraines. The purpose of this study is to clinically validate the efficacy and safety of Sleepaxa Migraine Glasses in the preventive treatment of common migraine. By evaluating the reduction in migraine frequency, intensity, and duration, as well as improvements in eye fatigue, light sensitivity, stress, and mood, this study aims to provide robust evidence for the effectiveness of Sleepaxa Migraine Glasses as a preventive treatment for migraines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with a history of migraine without aura for at least 6 months prior to the screening visit for the study 2.Patients with light sensitivity and eye fatigue due to migraine 3.Patients experiencing 2-6 migraine attacks per month, but not more than 15 headache days per month 4.Male or female patients aged 18 to 60 years (both inclusive) 5.Patients willing to sign the informed consent form.
排除标准
- •Patients have more than 15 headache days per month or less than 2 migraine attacks per month
- •Patients have more than 6 attacks per year of migraine with aura
- •Pregnant women or nursing mothers
- •Women of child-bearing potential & all men not willing to follow a reliable & effective contraceptive measure during the course of the study
- •Patients headache attacks are associated with or attributable to an identifiable cause such as premenstrual period a disease of eye ear or nose a neurological disease or a psychiatric illness
- •Any known refractive errors.
结局指标
主要结局
1. Assessment of changes in the frequency of migraine headaches by using migraine diary/headache diary.
时间窗: Baseline, Day 7, Day 14, Day 28
次要结局
- 1.Assessment of changes in the intensity and duration of migraine headaches from baseline to end of the study.(2.Patient-reported assessments of changes in eye fatigue and light sensitivity using Visual Analog Scales (VAS) from screening to end of the study.)
研究者
Dr Ninad Naik
Lokmanya Medical Research Centre and Hospital