EpilepsyEpiCapnoNCT01657084
Stopping and Preventing Epileptic Seizures Using a Partial Rebreathing Mask
A study testing CDA Mask and Dummy mask in people with Epilepsy, run by University of Aarhus at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- CDA Mask and Dummy mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2012to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Epilepsy
- 18-80 years
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University Hospital
Aarhus, 8000
The Epilepsy Hospital Filadelfia
Dianalund
About this study
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.
- Conditions
- Epilepsy
- Being tested
- CDA Mask, Dummy mask
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDA MaskDevice
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 maskDevice
The dummy mask is similar in appearance to the treatment mask, but causes only a negligible change in blood gases
| Study group | Role | What they receive |
|---|---|---|
| Tonic-clonic seizures | Experimental | 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. Receives: Device: CDA Mask; Device: Dummy mask |
| Generalized Paroxysms | Experimental | 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. Receives: Device: CDA Mask; Device: Dummy mask |
| Group 3 | Experimental | Patients with epileptic paroxysms are observed by EEG during baseline, treatment mask and dummy mask use, according to a randomized cross-over study design. Receives: Device: CDA Mask; Device: Dummy mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of epileptic seizure (subgroup 1)
Length of epileptic seizure with treatment mask vs. dummy mask
Measured: 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)
Frequency of epileptic paroxysms as measured by EEG, treatment mask vs. dummy mask
Measured: Duration of mask treatment: 45 minutes (group 2) or 10 minutes (group 3) during which patient is monitored with EEG
Secondary outcomes (1)
Oxygen saturation during mask treatment
Measures oxygen saturation using a pulse oximeter during mask treatment
Measured: Duration of mask treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Jakob Christensen, M.D., Ph.d., Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657084
- Sponsor's protocol ID
- 2012051485
- Acronym
- EpiCapno
- Status last verified
- May 2016
- First submitted
- 1 Aug 2012
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stopping and Preventing Epileptic Seizures Using a Partial Rebreathing Mask
- ClinicalTrials.gov ID
- NCT01657084
- Acronym / sponsor ID
- EpiCapno / 2012051485
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 3 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tonic-clonic seizures | Experimental | Device: CDA Mask, Device: Dummy maskPatients 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 | Experimental | Device: CDA Mask, Device: Dummy maskPatients 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 | Experimental | Device: CDA Mask, Device: Dummy maskPatients with epileptic paroxysms are observed by EEG during baseline, treatment mask and dummy mask use, according to a randomized cross-over study design. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Epilepsy
- 18-80 years
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDA MaskThe 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 | Generalized Paroxysms, Group 3, Tonic-clonic seizures |
| Dummy maskThe dummy mask is similar in appearance to the treatment mask, but causes only a negligible change in blood gases | Device | Generalized Paroxysms, Group 3, Tonic-clonic seizures |
Primary outcome
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
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
1 secondary outcome
Oxygen saturation during mask treatment
Time frame: Duration of mask treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakob Christensen, M.D., Ph.d. principal investigator
Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDA Mask and Dummy mask in people with Epilepsy, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2016.