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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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By enabling a partial rebreathing of expired gas, a moderate respiratory acidosis is induced, without causing hypoxia in the patient.
Based on the scientific literature on the subject, the study hypothesis is that the fall in body pH will be able to stop and/or prevent epileptic brain activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tonic-clonic seizures | Experimental | Patients with tonic-clonis seizures are observed in a video/EEG room. In the case of seizures, the treatment mask or dummy mask are administered, according to a randomized cross-over study design. |
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| Generalized Paroxysms | Experimental | Patients with generalized epileptic paroxysms are observed by EEG during baseline, treatment mask and dummy mask use, according to a randomized cross-over study design. |
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| Group 3 | Experimental | Patients with epileptic paroxysms are observed by EEG during baseline, treatment mask and dummy mask use, according to a randomized cross-over study design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDA Mask | Device | The CDA (Carbon Dioxide Accumulation) mask effectuates an increase in the inspired CO2 fraction, while allowing an adequate supply of fresh air to the patient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of epileptic seizure (subgroup 1) | Length of epileptic seizure with treatment mask vs. dummy mask | Duration of mask treatment during acute seizures: approx. 3 minutes from start of mask treatment until end of seizure |
| Frequency of epileptic paroxysms (subgroups 2 and 3) | Frequency of epileptic paroxysms as measured by EEG, treatment mask vs. dummy mask | Duration of mask treatment: 45 minutes (group 2) or 10 minutes (group 3) during which patient is monitored with EEG |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen saturation during mask treatment | Measures oxygen saturation using a pulse oximeter during mask treatment | Duration of mask treatment |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Jakob Christensen, M.D., Ph.d. | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8000 | Denmark | |||
| The Epilepsy Hospital Filadelfia |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Dummy mask | Device | The dummy mask is similar in appearance to the treatment mask, but causes only a negligible change in blood gases |
|
| Dianalund |
| Denmark |