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OpenTrials
Completed

NCT Number: NCT01657084

Stopping and Preventing Epileptic Seizures Using a Partial Rebreathing Mask

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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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Aarhus, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Epilepsy
  • 18-80 years

Exclusion criteria

-

Treatment and study plan

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.

Dummy mask

Device

The dummy mask is similar in appearance to the treatment mask, but causes only a negligible change in blood gases

Primary outcomes

  1. Length of epileptic seizure (subgroup 1)

    Time frame: 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

  2. Frequency of epileptic paroxysms (subgroups 2 and 3)

    Time frame: 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 outcomes

  1. Oxygen saturation during mask treatment

    Time frame: Duration of mask treatment

    Measures oxygen saturation using a pulse oximeter during mask treatment

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Acronym: EpiCapno

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 3, 2012
Registry last updated
May 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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