NCT06149000

Migraine Headache Mitigation Utilizing Avulux

Migraine Headache Mitigation Utilizing Avulux Color Filtering Lenses

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Migraine
• Headache
• Photophobia

Interventions

Type	Name	Description
DEVICE	Avulux Lenses	Avulux lenses are specialized eyewear designed to reduce specific wavelengths of light to alleviate symptoms in individuals who experience light sensitivity and migraines
DEVICE	Placebo Lenses	Lenses that will look identical to Avulux lenses without the medical benefits

Timeline

• Start date: 2023-12-13
• Primary completion: 2024-06-13
• Completion: 2024-06-20
• First posted: 2023-11-28
• Last updated: 2023-11-28

Regulatory

• FDA-regulated device study