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Partial Rebreathing in the Treatment of Migraine With Aura (CapnoMigra)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03472417
Recruitment Status : Completed
First Posted : March 21, 2018
Last Update Posted : March 23, 2018
Sponsor:
Collaborators:
Aarhus University Hospital
BalancAir
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
A study to test the efficacy of a partial rebreathing device in treating and/or preventing migraine pain

Condition or disease Intervention/treatment Phase
Migraine With Aura Device: Active partial rebreathing device Device: Dummy partial rebreathing device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Partial Rebreathing in the Treatment of Migraine With Aura
Study Start Date : November 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Active Comparator: Active partial rebreathing device Device: Active partial rebreathing device
Sham Comparator: Dummy partial rebreathing device Device: Dummy partial rebreathing device



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Headache Intensity Difference at 0 and 1 hour post-treatment (0-3 point scale) [ Time Frame: 1 hour ]
    0-3 point scale (0 = none, 1 = mild, 2= moderate, 3 =severe)

  2. Pain reduction/relief at 1 hour [ Time Frame: 1 hour ]
    percentage of study participants reporting no or mild pain 1 hour after first using the device

  3. Pain reduction/relief at 2 hours [ Time Frame: 2 hours ]
    percentage of study participants reporting no or mild pain 2 hours after first using the device

  4. Nausea Intensity Difference 0 vs 1 hour post-treatment [ Time Frame: 1 hour ]
    0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)

  5. Nausea Intensity Difference 0 vs 2 hours post-treatment [ Time Frame: 2 hours ]
    0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)

  6. Photo - and/or phono-phobia Intensity Difference 0 vs 1 hour post-treatment [ Time Frame: 1 hour ]
    0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)

  7. Photo - and/or phono-phobia Intensity Difference 0 vs 2 hours post-treatment [ Time Frame: 2 hours ]
    0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)

  8. Functional Disability Difference 0 vs 1 hour post-treatment [ Time Frame: 1 hour ]
    0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)

  9. Functional Disability Difference 0 vs 2 hours post-treatment [ Time Frame: 2 hours ]
    0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)

  10. Sustained pain freedom at 24 hours [ Time Frame: 24 hours ]
    percentage of study participants who are pain free 24 hours after device use

  11. Treatment preference vs. patient's normal treatment [ Time Frame: 24 hours ]
    -2 to +2 scale ((-2 = much worse than normal treatment, - 1 = somewhat worse, 0 = no difference, +1 = somewhat better, +2 = much better))

  12. Aura symptoms aborted after one use of device [ Time Frame: 20 minutes ]
    yes/no

  13. Side effects [ Time Frame: through study completion (1 to 10 months) ]
    Qualitative analysis

  14. Adverse events [ Time Frame: through study completion (1 to 10 months) ]
    Qualitative analysis

  15. Medicine use in 24 hours after device use [ Time Frame: 24 hours ]
    qualitative comparison



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • - 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

Exclusion Criteria:

  • - 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472417


Locations
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Denmark
Pain and Headache Clinic, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
BalancAir
Investigators
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Principal Investigator: Flemming W Bach, MD, PhD Aarhus University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03472417     History of Changes
Other Study ID Numbers: 2016-003683-39
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Migraine Disorders
Migraine with Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases