An interventional study of Lenses in Migraine, Glasses and Headache, sponsored by Rune Skovgaard Rasmussen. Not yet recruiting at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-09.
Sponsored by Rune Skovgaard Rasmussen · Not applicable, Interventional, and Treatment
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.
Migraine is a neurological disorder that often causes severe, throbbing headaches that can be accompanied by nausea and vomiting. In addition, sound or light sensitivity is often seen. An attack can last up to 72 hours. Migraine can occur in one half of the head and is exacerbated by physical activity. There are several different types of migraine, of which the inherited migraine typically cannot be cured. Migraine affects about 15% of all adults worldwide, but about twice as many women as men.
About 10% of diagnosed patients have chronic migraine, which is characterized by at least 15 days of severe headache each month. Many patients have tension headaches between attacks.
Migraine most often starts in the most productive years of life, between the ages of 20 and 50, and most affects the age group of 35-54 years. For many women, migraine debuts after childbirth, while others experience that it disappears after childbirth. Several women experience that they get migraine when they have their period. This migraine is called hormonal and can follow them for many years.
Several studies have shown that migraine attacks are triggered by light, and many become very light-sensitive during an attack. So far, a FL 41 lens, which excludes blue-green light, has been the only migraine-specific optical treatment.
A new lens called "Blue Cut for Night Glass" has in a study resulted in participants experiencing less migraine. For 4 weeks, 10 participants used only the lens in the evening. Results showed that they had fewer days with headaches. The lens is so new that it has not yet come into regular production and trade. In connection with the present study, the investigators have received 13 sets of lenses.
For many years, FL-41 has been the preferred filter lens for the prevention of migraine attacks, since it was first successfully tested on children in 1991. Since this study, much has happened in terms of the development of filter lenses.
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.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 200 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Rune Skovgaard Rasmussen is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Group of 50 participants (control) will receive glasses with clear lenses.
Group of 50 participants will receive a glasses with an FL-41 filter.
Device: Lenses
Group of 50 participants will receive glasses with a Blue Cut filter.
Device: Lenses
Group of 50 participants will receive glasses with a below 500 nm filter
Device: Lenses
The filter lenses will be worn by participants for one month all day.
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 inclusion
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 inclusion
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 inclusion
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 weeks
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 inclusion
Groffman Visual Tracing Test
Test for assessment of attention, visuospatial function, and figure-ground perception. The test is stressful and requires a high degree of sustained visual focus, and can be expected to be affected by pain, fatigue, light sensitivity, and oculomotor dysfunction
Time frame: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
The Migraine Disability Assessment Test
The questionnaire is changed to a 1-month focus period instead of 3 months. The Migraine Disability Assessment Test is frequently used to measure the effectiveness of interventions for migraine
Time frame: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
Medication use, both as needed (PN) and daily fixed medication
Consumption of preparations and dosage is recorded in a diary
Time frame: Every day of participation lasting 8 weeks
Major Depression Inventory
About 80% of people with chronic migraine are affected by depression. Major Depression Inventory is used in the present study to monitor for symptoms of depression as well as part of the assessment of mental well-being and quality of life
Time frame: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
The 36-Item Health Survey
The 36-Item Health Survey is used to measure quality of life and is frequently used to measure the effectiveness of different treatments for headache-affected persons. The questionnaire has 8 dimensions ranging for 0 to 100 points, where a high score indicates better functioning. The 8 dimensions are: physical functioning, role physical, bodily pain, general health perceptions, vitality, social function, role emotional, og mental health.
Time frame: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
Assessment of photophobia via questionnaire
Assessment of photophobia via questionnaire, where each participant assesses their own light sensitivity during the day, at night, and indoors. This is done both with and without filter glasses. The amount of photophobia is measured on a scale from 0 to 10, where 10 indicates maximum and worst photophobia.
Time frame: Measured at inclusion, 4 weeks after inclusion, and 8 weeks after inclusion
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2026; primary completion for Aug 2028, 29 months later.
Of 309 non-industry interventional studies with no phase under Migraine Disorders, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 29 months is above that.
Counting every sponsor, half of 358 studies reached it within 15 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Rune Skovgaard Rasmussen