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

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
CDA Mask
Dummy mask
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Epilepsy
  • 18-80 years

Exclusion Criteria:

-

Sites / Locations

  • Aarhus University Hospital
  • The Epilepsy Hospital Filadelfia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Tonic-clonic seizures

Generalized Paroxysms

Group 3

Arm Description

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.

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.

Patients with epileptic paroxysms are observed by EEG during baseline, treatment mask and dummy mask use, according to a randomized cross-over study design.

Outcomes

Primary Outcome Measures

Length of epileptic seizure (subgroup 1)
Length of epileptic seizure with treatment mask vs. dummy mask
Frequency of epileptic paroxysms (subgroups 2 and 3)
Frequency of epileptic paroxysms as measured by EEG, treatment mask vs. dummy mask

Secondary Outcome Measures

Oxygen saturation during mask treatment
Measures oxygen saturation using a pulse oximeter during mask treatment

Full Information

First Posted
August 1, 2012
Last Updated
May 19, 2016
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01657084
Brief Title
Stopping and Preventing Epileptic Seizures Using a Partial Rebreathing Mask
Acronym
EpiCapno
Official Title
Stopping and Preventing Epileptic Seizures Using a Partial Rebreathing Mask
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tonic-clonic seizures
Arm Type
Experimental
Arm Description
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.
Arm Title
Generalized Paroxysms
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Patients with epileptic paroxysms are observed by EEG during baseline, treatment mask and dummy mask use, according to a randomized cross-over study design.
Intervention Type
Device
Intervention Name(s)
CDA Mask
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Dummy mask
Intervention Description
The dummy mask is similar in appearance to the treatment mask, but causes only a negligible change in blood gases
Primary Outcome Measure Information:
Title
Length of epileptic seizure (subgroup 1)
Description
Length of epileptic seizure with treatment mask vs. dummy mask
Time Frame
Duration of mask treatment during acute seizures: approx. 3 minutes from start of mask treatment until end of seizure
Title
Frequency of epileptic paroxysms (subgroups 2 and 3)
Description
Frequency of epileptic paroxysms as measured by EEG, treatment mask vs. dummy mask
Time Frame
Duration of mask treatment: 45 minutes (group 2) or 10 minutes (group 3) during which patient is monitored with EEG
Secondary Outcome Measure Information:
Title
Oxygen saturation during mask treatment
Description
Measures oxygen saturation using a pulse oximeter during mask treatment
Time Frame
Duration of mask treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Epilepsy 18-80 years Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakob Christensen, M.D., Ph.d.
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
The Epilepsy Hospital Filadelfia
City
Dianalund
Country
Denmark

12. IPD Sharing Statement

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Stopping and Preventing Epileptic Seizures Using a Partial Rebreathing Mask

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