Partial Rebreathing in the Treatment of Migraine With Aura

Study Overview
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Brief Summary
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A study to test the efficacy of a partial rebreathing device in treating and/or preventing migraine pain

Official Title
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Partial Rebreathing in the Treatment of Migraine With Aura

Conditions
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Migraine With Aura

Intervention / Treatment
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* Device: Active partial rebreathing device
* Device: Dummy partial rebreathing device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Migraine with aura Attack frequency of between one and six migraine-with-aura attacks per month over the last six months Adults (18-60 years) Age at onset of migraine < 50 years If taking migraine prophylactic drugs, the dosis must have been stable for > 3 months Must speak and understand Danish Exclusion Criteria: - Cardiovascular disease, pulmonary disease, metabolic acid/base disorder, cancer, moderate and severe depression, anemia or other blood disease Chronic migraine, i.e. more than 15 headache days per month over the last three months Medication overuse headache More than six migraine-with-aura attacks per month Non-migraine headache on more than six days per month A typical duration between migraine-with-aura attacks of less than 48 hours

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active partial rebreathing device<br> | Device: Active partial rebreathing device<br> <br> |
| Sham Comparator: Dummy partial rebreathing device<br> | Device: Dummy partial rebreathing device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache Intensity Difference at 0 vs 2 hours post-treatment | 0-3 point scale (0 = none, 1 = mild, 2= moderate, 3 =severe) | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache Intensity Difference at 0 and 1 hour post-treatment (0-3 point scale) | 0-3 point scale (0 = none, 1 = mild, 2= moderate, 3 =severe) | 1 hour | 
| Pain reduction/relief at 1 hour | percentage of study participants reporting no or mild pain 1 hour after first using the device | 1 hour | 
| Pain reduction/relief at 2 hours | percentage of study participants reporting no or mild pain 2 hours after first using the device | 2 hours | 
| Nausea Intensity Difference 0 vs 1 hour post-treatment | 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe) | 1 hour | 
| Nausea Intensity Difference 0 vs 2 hours post-treatment | 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe) | 2 hours | 
| Photo - and/or phono-phobia Intensity Difference 0 vs 1 hour post-treatment | 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe) | 1 hour | 
| Photo - and/or phono-phobia Intensity Difference 0 vs 2 hours post-treatment | 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe) | 2 hours | 
| Functional Disability Difference 0 vs 1 hour post-treatment | 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe) | 1 hour | 
| Functional Disability Difference 0 vs 2 hours post-treatment | 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe) | 2 hours | 
| Sustained pain freedom at 24 hours | percentage of study participants who are pain free 24 hours after device use | 24 hours | 
| Treatment preference vs. patient's normal treatment | -2 to +2 scale ((-2 = much worse than normal treatment, - 1 = somewhat worse, 0 = no difference, +1 = somewhat better, +2 = much better)) | 24 hours | 
| Aura symptoms aborted after one use of device | yes/no | 20 minutes | 
| Side effects | Qualitative analysis | through study completion (1 to 10 months) | 
| Adverse events | Qualitative analysis | through study completion (1 to 10 months) | 
| Medicine use in 24 hours after device use | qualitative comparison | 24 hours |