Migraine With AuraCapnoMigraNCT03472417
Partial Rebreathing in the Treatment of Migraine With Aura
A study testing Active partial rebreathing device and Dummy partial rebreathing device in people with Migraine With Aura, run by University of Aarhus at 1 site in Denmark.
Trial summary
A study to test the efficacy of a partial rebreathing device in treating and/or preventing migraine pain Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Migraine With Aura
- What is being tested?
- Active partial rebreathing device and Dummy partial rebreathing device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2016to Sep 2017
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - Migraine with aura
- Attack frequency of between one and six migraine-with-aura attacks per month over the last six months
- Adults (18-60 years)
- Age at onset of migraine < 50 years
- If taking migraine prophylactic drugs, the dosis must have been stable for > 3 months
- Must speak and understand Danish
Who cannot join
- - Cardiovascular disease, pulmonary disease, metabolic acid/base disorder, cancer, moderate and severe depression, anemia or other blood disease
- Chronic migraine, i.e. more than 15 headache days per month over the last three months
- Medication overuse headache
- More than six migraine-with-aura attacks per month
- Non-migraine headache on more than six days per month
- A typical duration between migraine-with-aura attacks of less than 48 hours
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Pain and Headache Clinic, Aarhus University Hospital
Aarhus, 8000
About this study
A study to test the efficacy of a partial rebreathing device in treating and/or preventing migraine pain
- Conditions
- Migraine With Aura
- Being tested
- Active partial rebreathing device, Dummy partial rebreathing device
- Medical subject headings
- Migraine with Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active partial rebreathing deviceDevice
Dummy partial rebreathing deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| Active partial rebreathing device | Active comparator | Not described Receives: Device: Active partial rebreathing device |
| Dummy partial rebreathing device | Sham comparator | Not described Receives: Device: Dummy partial rebreathing device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Intensity Difference at 0 vs 2 hours post-treatment
0-3 point scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
Measured: 2 hours
Secondary outcomes (15)
Headache Intensity Difference at 0 and 1 hour post-treatment (0-3 point scale)
0-3 point scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
Measured: 1 hour
Pain reduction/relief at 1 hour
percentage of study participants reporting no or mild pain 1 hour after first using the device
Measured: 1 hour
Pain reduction/relief at 2 hours
percentage of study participants reporting no or mild pain 2 hours after first using the device
Measured: 2 hours
Nausea Intensity Difference 0 vs 1 hour post-treatment
0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
Measured: 1 hour
Nausea Intensity Difference 0 vs 2 hours post-treatment
0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
Measured: 2 hours
Photo - and/or phono-phobia Intensity Difference 0 vs 1 hour post-treatment
0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
Measured: 1 hour
Photo - and/or phono-phobia Intensity Difference 0 vs 2 hours post-treatment
0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
Measured: 2 hours
Functional Disability Difference 0 vs 1 hour post-treatment
0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
Measured: 1 hour
Functional Disability Difference 0 vs 2 hours post-treatment
0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
Measured: 2 hours
Sustained pain freedom at 24 hours
percentage of study participants who are pain free 24 hours after device use
Measured: 24 hours
Treatment preference vs. patient's normal treatment
-2 to +2 scale ((-2 = much worse than normal treatment, - 1 = somewhat worse, 0 = no difference, +1 = somewhat better, +2 = much better))
Measured: 24 hours
Aura symptoms aborted after one use of device
yes/no
Measured: 20 minutes
Side effects
Qualitative analysis
Measured: through study completion (1 to 10 months)
Adverse events
Qualitative analysis
Measured: through study completion (1 to 10 months)
Medicine use in 24 hours after device use
qualitative comparison
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study startNov 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migraine With AuraStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Rehaler
- Responsible party
- Sponsor
- Investigators
- Flemming W Bach, MD, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472417
- Sponsor's protocol ID
- 2016-003683-39
- Other IDs
- 2016
- Acronym
- CapnoMigra
- Status last verified
- Nov 2016
- First submitted
- 2 May 2017
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fuglsang CH, Johansen T, Kaila K, Kasch H, Bach FW. Treatment of acute migraine by a partial rebreathing device: A randomized controlled pilot study. Cephalalgia. 2018 Sep;38(10):1632-1643. doi: 10.1177/0333102418797285. Epub 2018 Aug 22.
PubMed 30134739
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Rebreathing in the Treatment of Migraine With Aura
- ClinicalTrials.gov ID
- NCT03472417
- Acronym / sponsor ID
- CapnoMigra / 2016-003683-39
- Conditions
- Migraine With Aura
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Rehaler
- Study start
- Nov 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 21 Mar 2018 (actual)
- 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.
A study to test the efficacy of a partial rebreathing device in treating and/or preventing migraine pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active partial rebreathing device | Active comparator | Device: Active partial rebreathing device |
| Dummy partial rebreathing device | Sham comparator | Device: Dummy partial rebreathing device |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- - Migraine with aura
- Attack frequency of between one and six migraine-with-aura attacks per month over the last six months
- Adults (18-60 years)
- Age at onset of migraine < 50 years
- If taking migraine prophylactic drugs, the dosis must have been stable for > 3 months
Key exclusion criteria (6 listed)
- - Cardiovascular disease, pulmonary disease, metabolic acid/base disorder, cancer, moderate and severe depression, anemia or other blood disease
- Chronic migraine, i.e. more than 15 headache days per month over the last three months
- Medication overuse headache
- More than six migraine-with-aura attacks per month
- Non-migraine headache on more than six days per month
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 |
|---|---|---|
| Active partial rebreathing device | Device | Active partial rebreathing device |
| Dummy partial rebreathing device | Device | Dummy partial rebreathing device |
Primary outcome
Headache Intensity Difference at 0 vs 2 hours post-treatment
Time frame: 2 hours
0-3 point scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
15 secondary outcomes
Headache Intensity Difference at 0 and 1 hour post-treatment (0-3 point scale)
Time frame: 1 hour
Pain reduction/relief at 1 hour
Time frame: 1 hour
Pain reduction/relief at 2 hours
Time frame: 2 hours
Nausea Intensity Difference 0 vs 1 hour post-treatment
Time frame: 1 hour
Nausea Intensity Difference 0 vs 2 hours post-treatment
Time frame: 2 hours
Photo - and/or phono-phobia Intensity Difference 0 vs 1 hour post-treatment
Time frame: 1 hour
Photo - and/or phono-phobia Intensity Difference 0 vs 2 hours post-treatment
Time frame: 2 hours
Functional Disability Difference 0 vs 1 hour post-treatment
Time frame: 1 hour
Functional Disability Difference 0 vs 2 hours post-treatment
Time frame: 2 hours
Sustained pain freedom at 24 hours
Time frame: 24 hours
Treatment preference vs. patient's normal treatment
Time frame: 24 hours
Aura symptoms aborted after one use of device
Time frame: 20 minutes
Side effects
Time frame: through study completion (1 to 10 months)
Adverse events
Time frame: through study completion (1 to 10 months)
Medicine use in 24 hours after device use
Time frame: 24 hours
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 23 Mar 2018.
- Derived from this study: PubMed 30134739Fuglsang CH, Johansen T, Kaila K, Kasch H, Bach FW. Treatment of acute migraine by a partial rebreathing device: A randomized controlled pilot study. Cephalalgia. 2018 Sep;38(10):1632-1643. doi: 10.1177/0333102418797285. Epub 2018 Aug 22.
- Individual participant dataSharing planned: No
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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.
Flemming W Bach, MD, PhD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active partial rebreathing device and Dummy partial rebreathing device in people with Migraine With Aura, run by University of Aarhus at 1 site 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 6 inclusion and 6 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 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Headache Intensity Difference at 0 vs 2 hours post-treatment (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03472417, which also lists 1 linked publication.
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 23 Mar 2018.