Migraine Headache Mitigation Utilizing Avulux

Study Overview
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Brief Summary
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This will be a randomized double blind cross over interventional trial to determine if Avulux lenses are able to reduce headache symptoms in patients

Detailed Description
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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: Participants will complete a baseline assessment and self-report migraine frequency using the Redcap migraine diary application. Participants will complete testing sessions with both Avulux and placebo lenses for the duration of 3 months and then switch lenses for the remaining 3 months for comparison and a total study period of 6 months.

Official Title
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Migraine Headache Mitigation Utilizing Avulux Color Filtering Lenses

Conditions
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Migraine, Headache, Photophobia

Intervention / Treatment
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* Device: Avulux Lenses
* Device: Placebo Lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient population: Individuals must have an existing diagnosis code of G43.1 (migraine w aura) or G43. 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avulux Lenses<br>This group will be receiving migraine treatment using Avulux lenses | Device: Avulux Lenses<br>* Avulux lenses are specialized eyewear designed to reduce specific wavelengths of light to alleviate symptoms in individuals who experience light sensitivity and migraines<br>Device: Placebo Lenses<br>* Lenses that will look identical to Avulux lenses without the medical benefits<br>|
| Placebo Comparator: Placebo Lenses<br>This group will be using identical placebo lenses as treatment | Device: Avulux Lenses<br>* Avulux lenses are specialized eyewear designed to reduce specific wavelengths of light to alleviate symptoms in individuals who experience light sensitivity and migraines<br>Device: Placebo Lenses<br>* Lenses that will look identical to Avulux lenses without the medical benefits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in migraine frequency | headache days per month documented in a headache diary. | 6 months | 
| Reduction in migraine severity | Severity of headaches on a scale from no, mild, moderate, and sever pain | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve quality of life | Rating of daily activity performance using Functional Disability Scale (0) No disability-(6) Severe disability | 6 months | 
| Medication Use | Number of medications used as a form of rescue medication during episode of migraine | 6 months |