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

May 19, 2016 updated by: University of Aarhus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital
      • Dianalund, Denmark
        • The Epilepsy Hospital Filadelfia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Epilepsy
  • 18-80 years

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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
Duration of mask treatment: 45 minutes (group 2) or 10 minutes (group 3) during which patient is monitored with EEG

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen saturation during mask treatment
Time Frame: Duration of mask treatment
Measures oxygen saturation using a pulse oximeter during mask treatment
Duration of mask treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital

Investigators

  • Principal Investigator: Jakob Christensen, M.D., Ph.d., Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 1, 2012

First Submitted That Met QC Criteria

August 1, 2012

First Posted (Estimate)

August 3, 2012

Study Record Updates

Last Update Posted (Estimate)

May 20, 2016

Last Update Submitted That Met QC Criteria

May 19, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012051485

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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