Migraine Headache Mitigation Utilizing Avulux

Kaiser Permanente

Status: Not yet enrolling

Conditions: Photophobia; Migraine; Headache

Treatments: Device: Placebo Lenses; Device: Avulux Lenses

Study type: Interventional

Funder types: Other

Identifiers

NCT06149000

Avulux

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Avulux Lenses

Experimental group

Description:

This group will be receiving migraine treatment using Avulux lenses

Treatment:

Device: Placebo Lenses

Device: Avulux Lenses

Placebo Lenses

Placebo Comparator group

Description:

This group will be using identical placebo lenses as treatment

Treatment:

Device: Placebo Lenses

Device: Avulux Lenses