Filter Lenses for the Prevention of Migraine Attacks
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRune Skovgaard Rasmussen
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult individuals below the age of 66.
Diagnosed with migraine by a neurologist.
Able to communicate in Danish
Able to voluntarily come to the clinic during an untreated migraine attack.
Disqualifiers
Fewer than four migraine attacks per month.
Chronic neck pain
Chronic headache
Chronic use of opioids
Trial design
Design model
Parallel
Treatments tested in this trial
Lenses
DeviceThe filter lenses will be worn by participants for one month all day.
Treatment groups
200 Participants
are divided into 4 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: FL-41Active comparator 1 intervention
Group C: BlueCutActive comparator 1 intervention
Group D: 500nmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change of pain intensity during migraine attacks
Intensity is described from 1-10 on a visual analog pain scale (VAS). A score of 1 is very mild intensity and 10 is very severe.
Time frame
Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusionSecondary outcomes
1
Headache Impact Test (HIT-6)
Headache Impact Test (HIT-6), which is a validated questionnaire. It consists of 6 questions and assesses participants' functional status in the past 4 weeks. The questions measure the frequency and severity of headaches, as well as their consequences for the participant's activity level. The scale scores from 36 to 78, with a high score being the worst. This questionnaire is recommended by the Danish Medicines Council for Danish migraine patients
Time frame
Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion2
Migraine-Specific Quality-of-Life Questionnaire v. 2.1 (MSQ)
MSQ is a frequently used disease-specific survey for assessing health-related quality of life in people with migraine. MSQ is validated for persons with episodic migraine and persons with chronic migraine. MSQ measures quality of life within the last 4 weeks in relation to restrictive function, preventive function, and emotional function. The score ranges from 0-100, with a higher score indicating improvement in quality of life
Time frame
Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion3
Monthly migraine days
The date of the migraine attack, duration, and medication used are noted. A migraine day is defined as a day on which the person experienced a migraine attack or used medication to relieve acute attacks
Time frame
Every day of participation lasting 8 weeks4
Fatigue Severity Scale
Short fatigue questionnaire used to assess the occurrence of disabling fatigue. There are 9 items scored from 1 to 7, where 7 indicated the most fatigue. A score of 63 is worst, and disabling fatigue may be observed scoring 45 or more points.
Time frame
Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rune Skovgaard Rasmussen
Lead sponsor
University Hospital, Gentofte, Copenhagen
Sponsor institution
Center of Communication (CSU-Slagelse)
Collaborator
Source ClinicalTrials.gov
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