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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Rehaler | INDUSTRY |
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A study to test the efficacy of a partial rebreathing device in treating and/or preventing migraine pain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active partial rebreathing device | Active Comparator |
| |
| Dummy partial rebreathing device | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active partial rebreathing device | Device |
| ||
| Dummy partial rebreathing device |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Flemming W Bach, MD, PhD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain and Headache Clinic, Aarhus University Hospital | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30134739 | Derived | Fuglsang CH, Johansen T, Kaila K, Kasch H, Bach FW. Treatment of acute migraine by a partial rebreathing device: A randomized controlled pilot study. Cephalalgia. 2018 Sep;38(10):1632-1643. doi: 10.1177/0333102418797285. Epub 2018 Aug 22. |
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| ID | Term |
|---|---|
| D020325 | Migraine with Aura |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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| 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 |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |