Migraine With Aura
Conditions
Brief summary
A study to test the efficacy of a partial rebreathing device in treating and/or preventing migraine pain
Interventions
DEVICEActive partial rebreathing device
DEVICEDummy partial rebreathing device
Sponsors
Aarhus University Hospital
Rehaler
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache Intensity Difference at 0 vs 2 hours post-treatment | 2 hours | 0-3 point scale (0 = none, 1 = mild, 2= moderate, 3 =severe) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nausea Intensity Difference 0 vs 2 hours post-treatment | 2 hours | 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe) |
| Photo - and/or phono-phobia Intensity Difference 0 vs 1 hour post-treatment | 1 hour | 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe) |
| Photo - and/or phono-phobia Intensity Difference 0 vs 2 hours post-treatment | 2 hours | 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe) |
| Headache Intensity Difference at 0 and 1 hour post-treatment (0-3 point scale) | 1 hour | 0-3 point scale (0 = none, 1 = mild, 2= moderate, 3 =severe) |
| Pain reduction/relief at 1 hour | 1 hour | percentage of study participants reporting no or mild pain 1 hour after first using the device |
| Pain reduction/relief at 2 hours | 2 hours | percentage of study participants reporting no or mild pain 2 hours after first using the device |
| Functional Disability Difference 0 vs 1 hour post-treatment | 1 hour | 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe) |
| Nausea Intensity Difference 0 vs 1 hour post-treatment | 1 hour | 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe) |
| Sustained pain freedom at 24 hours | 24 hours | percentage of study participants who are pain free 24 hours after device use |
| Treatment preference vs. patient's normal treatment | 24 hours | -2 to +2 scale ((-2 = much worse than normal treatment, - 1 = somewhat worse, 0 = no difference, +1 = somewhat better, +2 = much better)) |
| Aura symptoms aborted after one use of device | 20 minutes | yes/no |
| Side effects | through study completion (1 to 10 months) | Qualitative analysis |
| Adverse events | through study completion (1 to 10 months) | Qualitative analysis |
| Medicine use in 24 hours after device use | 24 hours | qualitative comparison |
| Functional Disability Difference 0 vs 2 hours post-treatment | 2 hours | 0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe) |
Countries
Denmark
Outcome results
None listed