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Completed

NCT Number: NCT03472417

Partial Rebreathing in the Treatment of Migraine With Aura

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

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Key information

Conditions

Migraine With Aura Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pain and Headache Clinic, Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active partial rebreathing device

Device

Dummy partial rebreathing device

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • Rehaler

Registry information

Acronym: CapnoMigra

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 21, 2018
Registry last updated
Mar 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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