Stopping and Preventing Epileptic Seizures Using a Partial Rebreathing Mask

NCT ID: NCT01657084

Last Updated: 2016-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

CDA Mask

Intervention Type 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

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

CDA Mask

Intervention Type 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

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

CDA Mask

Intervention Type 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

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Dummy mask

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Epilepsy
* 18-80 years

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jakob Christensen, M.D., Ph.d.

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status

The Epilepsy Hospital Filadelfia

Dianalund, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2012051485

Identifier Type: -

Identifier Source: org_study_id

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