Epilepsy
Conditions
Brief summary
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.
Interventions
DEVICECDA Mask
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.
DEVICEDummy mask
The dummy mask is similar in appearance to the treatment mask, but causes only a negligible change in blood gases
Sponsors
Aarhus University Hospital
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Epilepsy * 18-80 years
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of epileptic seizure (subgroup 1) | Duration of mask treatment during acute seizures: approx. 3 minutes from start of mask treatment until end of seizure | Length of epileptic seizure with treatment mask vs. dummy mask |
| Frequency of epileptic paroxysms (subgroups 2 and 3) | Duration of mask treatment: 45 minutes (group 2) or 10 minutes (group 3) during which patient is monitored with EEG | Frequency of epileptic paroxysms as measured by EEG, treatment mask vs. dummy mask |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen saturation during mask treatment | Duration of mask treatment | Measures oxygen saturation using a pulse oximeter during mask treatment |
Countries
Denmark
Outcome results
None listed