Stopping and Preventing Epileptic Seizures Using a Partial Rebreathing Mask

Not Applicable

Completed

• Conditions: Epilepsy
• Interventions: Device: CDA Mask; Device: Dummy mask

• Registration Number: NCT01657084
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-08-01
• Study First Submitted QC: 2012-08-01
• Study First Posted: 2012-08-03
• Study Start: 2012-09
• Primary Completion: 2015-09
• Study Completion: 2015-11
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-19
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Epilepsy
• 18-80 years

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tonic-clonic seizures	CDA Mask	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.
Generalized Paroxysms	CDA Mask	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.
Tonic-clonic seizures	Dummy mask	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.
Generalized Paroxysms	Dummy mask	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 3	CDA Mask	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 3	Dummy mask	Patients with epileptic paroxysms are observed by EEG during baseline, treatment mask and dummy mask use, according to a randomized cross-over study design.

Primary Outcome Measures

Name	Time	Method
Length of epileptic seizure (subgroup 1)	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)	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

Name	Time	Method
Oxygen saturation during mask treatment	Duration of mask treatment	Measures oxygen saturation using a pulse oximeter during mask treatment

Trial Locations

Locations (2)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

The Epilepsy Hospital Filadelfia; 🇩🇰 Dianalund, Denmark