Filter Lenses for the Prevention of Migraine Attacks

Sponsor
Rune Skovgaard Rasmussen
Study ID
NCT06161129
Status
Not Yet Recruiting

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Conditions

  • Glasses
  • Headache
  • Migraine
  • Visual Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Lenses — DEVICE
    The filter lenses will be worn by participants for one month all day.

Study Details

The purpose is to investigate whether the Blue Cut for Night filter is better at reducing migraine compared to the FL-41 filter or a filter blocking light below 500 nm. A control group will use clear lenses without filter. This is a controlled, randomized and double-blind trial.

Key Dates

First listed
Dec 7, 2023
Start date
Mar 1, 2026
Status verified
Dec 2024
Primary completion
Aug 31, 2028
Completion
Feb 1, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control
    Group of 50 participants (control) will receive glasses with clear lenses.
  • Active Comparator: FL-41
    Group of 50 participants will receive a glasses with an FL-41 filter.
  • Active Comparator: BlueCut
    Group of 50 participants will receive glasses with a Blue Cut filter.
  • Active Comparator: 500nm
    Group of 50 participants will receive glasses with a below 500 nm filter

Primary Outcome Measure

Change of pain intensity during migraine attacks [ Time Frame: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion ]

Central Contacts

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