Stopping and Preventing Epileptic Seizures Using a Partial Rebreathing Mask

Epilepsy Clinical Trial

— EpiCapno  

Official title:

Stopping and Preventing Epileptic Seizures Using a Partial Rebreathing Mask

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657084
• Other study ID #: 2012051485
• Status: Completed
• Phase: N/A
• First received: August 1, 2012
• Last updated: May 19, 2016
• Start date: September 2012
• Est. completion date: November 2015

Study information

• Verified date: May 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Epilepsy

• 18-80 years

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	The Epilepsy Hospital Filadelfia	Dianalund

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of epileptic seizure (subgroup 1)	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	No
Primary	Frequency of epileptic paroxysms (subgroups 2 and 3)	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	No
Secondary	Oxygen saturation during mask treatment	Measures oxygen saturation using a pulse oximeter during mask treatment	Duration of mask treatment	Yes