Kaiser Permanente
This will be a randomized double blind cross over interventional trial to determine if Avulux lenses are able to reduce headache symptoms in patients
Migraine
Headache
Photophobia
Avulux Lenses
Placebo Lenses
NA
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 40 participants |
| Masking : | DOUBLE |
| Masking Description : | Neither the participants or the researchers will know which treatment is being received during the trial. This will be achieved by using identical looking placebos for control and ensuring all aspects of the treatment administration and assessment are indistinguishable. |
| Primary Purpose : | PREVENTION |
| Official Title : | Migraine Headache Mitigation Utilizing Avulux Color Filtering Lenses |
| Actual Study Start Date : | 2023-12-13 |
| Estimated Primary Completion Date : | 2024-06-13 |
| Estimated Study Completion Date : | 2024-06-20 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 120 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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