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

Primary Purpose

Migraine With Aura

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Active partial rebreathing device
Dummy partial rebreathing device
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine With Aura

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pain and Headache Clinic, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active partial rebreathing device

Dummy partial rebreathing device

Arm Description

Outcomes

Primary Outcome Measures

Headache Intensity Difference at 0 vs 2 hours post-treatment
0-3 point scale (0 = none, 1 = mild, 2= moderate, 3 =severe)

Secondary Outcome Measures

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)
Pain reduction/relief at 1 hour
percentage of study participants reporting no or mild pain 1 hour after first using the device
Pain reduction/relief at 2 hours
percentage of study participants reporting no or mild pain 2 hours after first using the device
Nausea Intensity Difference 0 vs 1 hour post-treatment
0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
Nausea Intensity Difference 0 vs 2 hours post-treatment
0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
Photo - and/or phono-phobia Intensity Difference 0 vs 1 hour post-treatment
0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
Photo - and/or phono-phobia Intensity Difference 0 vs 2 hours post-treatment
0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
Functional Disability Difference 0 vs 1 hour post-treatment
0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
Functional Disability Difference 0 vs 2 hours post-treatment
0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
Sustained pain freedom at 24 hours
percentage of study participants who are pain free 24 hours after device use
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))
Aura symptoms aborted after one use of device
yes/no
Side effects
Qualitative analysis
Adverse events
Qualitative analysis
Medicine use in 24 hours after device use
qualitative comparison

Full Information

First Posted
May 2, 2017
Last Updated
March 21, 2018
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Rehaler
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1. Study Identification

Unique Protocol Identification Number
NCT03472417
Brief Title
Partial Rebreathing in the Treatment of Migraine With Aura
Acronym
CapnoMigra
Official Title
Partial Rebreathing in the Treatment of Migraine With Aura
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Rehaler

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With Aura

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active partial rebreathing device
Arm Type
Active Comparator
Arm Title
Dummy partial rebreathing device
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Active partial rebreathing device
Intervention Type
Device
Intervention Name(s)
Dummy partial rebreathing device
Primary Outcome Measure Information:
Title
Headache Intensity Difference at 0 vs 2 hours post-treatment
Description
0-3 point scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Headache Intensity Difference at 0 and 1 hour post-treatment (0-3 point scale)
Description
0-3 point scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
Time Frame
1 hour
Title
Pain reduction/relief at 1 hour
Description
percentage of study participants reporting no or mild pain 1 hour after first using the device
Time Frame
1 hour
Title
Pain reduction/relief at 2 hours
Description
percentage of study participants reporting no or mild pain 2 hours after first using the device
Time Frame
2 hours
Title
Nausea Intensity Difference 0 vs 1 hour post-treatment
Description
0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
Time Frame
1 hour
Title
Nausea Intensity Difference 0 vs 2 hours post-treatment
Description
0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
Time Frame
2 hours
Title
Photo - and/or phono-phobia Intensity Difference 0 vs 1 hour post-treatment
Description
0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
Time Frame
1 hour
Title
Photo - and/or phono-phobia Intensity Difference 0 vs 2 hours post-treatment
Description
0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
Time Frame
2 hours
Title
Functional Disability Difference 0 vs 1 hour post-treatment
Description
0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
Time Frame
1 hour
Title
Functional Disability Difference 0 vs 2 hours post-treatment
Description
0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)
Time Frame
2 hours
Title
Sustained pain freedom at 24 hours
Description
percentage of study participants who are pain free 24 hours after device use
Time Frame
24 hours
Title
Treatment preference vs. patient's normal treatment
Description
-2 to +2 scale ((-2 = much worse than normal treatment, - 1 = somewhat worse, 0 = no difference, +1 = somewhat better, +2 = much better))
Time Frame
24 hours
Title
Aura symptoms aborted after one use of device
Description
yes/no
Time Frame
20 minutes
Title
Side effects
Description
Qualitative analysis
Time Frame
through study completion (1 to 10 months)
Title
Adverse events
Description
Qualitative analysis
Time Frame
through study completion (1 to 10 months)
Title
Medicine use in 24 hours after device use
Description
qualitative comparison
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flemming W Bach, MD, PhD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain and Headache Clinic, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30134739
Citation
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.
Results Reference
derived

Learn more about this trial

Partial Rebreathing in the Treatment of Migraine With Aura

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