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Stopping and Preventing Epileptic Seizures Using a Partial Rebreathing Mask (EpiCapno)

This study is not yet open for participant recruitment.
Verified September 2012 by University of Aarhus
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01657084
First received: August 1, 2012
Last updated: September 12, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Epilepsy
 Device: CDA Mask
Device: Dummy mask

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Stopping and Preventing Epileptic Seizures Using a Partial Rebreathing Mask

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Length of epileptic seizure with treatment mask vs. dummy mask

  • Frequency of epileptic paroxysms (subgroup 2) [ Time Frame: Duration of mask treatment: 45 minutes during which patient is monitored with EEG ] [ Designated as safety issue: No ]
    Frequency of epileptic paroxysms as measured by EEG, treatment mask vs. dummy mask


Secondary Outcome Measures:
  • Oxygen saturation during mask treatment [ Time Frame: Duration of mask treatment ] [ Designated as safety issue: Yes ]
    Measures oxygen saturation using a pulse oximeter during mask treatment


Estimated Enrollment: 20
Study Start Date: September 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tonic-Clonic Seizures
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.
 Device: CDA 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.
Device: Dummy mask
The dummy mask is similar in appearance to the treatment mask, but causes only a negligible change in blood gases
Experimental: Generalized Paroxysms
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.
 Device: CDA 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.
Device: Dummy mask
The dummy mask is similar in appearance to the treatment mask, but causes only a negligible change in blood gases

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Epilepsy
  • 18-80 years

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657084

Contacts
Contact: Jakob Christensen, MD, PhD +45 60865899 JAKOB@FARM.AU.DK
Contact: Troels Johansen, M.Sc.Eng. + 40977313 troels.johansen@ki.au.dk

Locations
Denmark
Aarhus University Hospital Not yet recruiting
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Jakob Christensen, M.D., Ph.d. Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01657084     History of Changes
Other Study ID Numbers: 2012051485
Study First Received: August 1, 2012
Last Updated: September 12, 2012
Health Authority: Denmark: Danish Health and Medicines Authority
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013