Migraine Headache Mitigation Utilizing Avulux
- Conditions
- MigraineHeadachePhotophobia
- Interventions
- Device: Avulux LensesDevice: Placebo Lenses
- Registration Number
- NCT06149000
- Lead Sponsor
- Kaiser Permanente
- Brief 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Lenses Avulux Lenses This group will be using identical placebo lenses as treatment Avulux Lenses Avulux Lenses This group will be receiving migraine treatment using Avulux lenses Avulux Lenses Placebo Lenses This group will be receiving migraine treatment using Avulux lenses Placebo Lenses Placebo Lenses This group will be using identical placebo lenses as treatment
- Primary Outcome Measures
Name Time Method Reduction in migraine frequency 6 months headache days per month documented in a headache diary.
Reduction in migraine severity 6 months Severity of headaches on a scale from no, mild, moderate, and sever pain
- Secondary Outcome Measures
Name Time Method Improve quality of life 6 months Rating of daily activity performance using Functional Disability Scale (0) No disability-(6) Severe disability
Medication Use 6 months Number of medications used as a form of rescue medication during episode of migraine