Clinical trial NCT06149000: Migraine Headache Mitigation Utilizing Avulux
Official title: Migraine Headache Mitigation Utilizing Avulux Color Filtering Lenses
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Migraine
Headache
Photophobia
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in migraine frequency
timeFrame: 6 months
measure: Reduction in migraine severity
timeFrame: 6 months
Secondary outcomes:
measure: Improve quality of life
timeFrame: 6 months
measure: Medication Use
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Kaiser Permanente
name: Munish Sharma, OD/MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Posternack C, Kupchak P, Capriolo AI, Katz BJ. Targeting the intrinsically photosensitive retinal ganglion cell to reduce headache pain and light sensitivity in migraine: A randomized double-blind trial. J Clin Neurosci. 2023 Jul;113:22-31. doi: 10.1016/j.jocn.2023.04.015. Epub 2023 May 5.
citation: Katz BJ, Digre KB. Diagnosis, pathophysiology, and treatment of photophobia. Surv Ophthalmol. 2016 Jul-Aug;61(4):466-77. doi: 10.1016/j.survophthal.2016.02.001. Epub 2016 Feb 12.
citation: Wilkins AJ, Wilkinson P. A tint to reduce eye-strain from fluorescent lighting? Preliminary observations. Ophthalmic Physiol Opt. 1991 Apr;11(2):172-5. doi: 10.1111/j.1475-1313.1991.tb00217.x.
citation: Huang J, Zong X, Wilkins A, Jenkins B, Bozoki A, Cao Y. fMRI evidence that precision ophthalmic tints reduce cortical hyperactivation in migraine. Cephalalgia. 2011 Jun;31(8):925-36. doi: 10.1177/0333102411409076. Epub 2011 May 26.