We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01657084
First Posted: August 3, 2012
Last Update Posted: May 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
  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
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Stopping and Preventing Epileptic Seizures Using a Partial Rebreathing Mask

Resource links provided by NLM:


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 ]
    Length of epileptic seizure with treatment mask vs. dummy mask

  • 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 Outcome Measures:
  • Oxygen saturation during mask treatment [ Time Frame: Duration of mask treatment ]
    Measures oxygen saturation using a pulse oximeter during mask treatment


Enrollment: 10
Study Start Date: September 2012
Study Completion Date: November 2015
Primary Completion Date: September 2015 (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
Experimental: Group 3
Patients with 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Epilepsy
  • 18-80 years

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01657084


Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
The Epilepsy Hospital Filadelfia
Dianalund, Denmark
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Jakob Christensen, M.D., Ph.d. Aarhus University Hospital
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01657084     History of Changes
Other Study ID Numbers: 2012051485
First Submitted: August 1, 2012
First Posted: August 3, 2012
Last Update Posted: May 20, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms