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

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

Study Overview

• Status: Completed
• Conditions: Migraine With Aura
• Intervention / Treatment: Device: Active partial rebreathing device; Device: Dummy partial rebreathing device

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Pain and Headache Clinic, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 hour
Pain reduction/relief at 1 hour	percentage of study participants reporting no or mild pain 1 hour after first using the device	1 hour
Pain reduction/relief at 2 hours	percentage of study participants reporting no or mild pain 2 hours after first using the device	2 hours
Nausea Intensity Difference 0 vs 1 hour post-treatment	0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)	1 hour
Nausea Intensity Difference 0 vs 2 hours post-treatment	0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)	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)	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)	2 hours
Functional Disability Difference 0 vs 1 hour post-treatment	0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)	1 hour
Functional Disability Difference 0 vs 2 hours post-treatment	0-3 scale (0 = none, 1 = mild, 2= moderate, 3 =severe)	2 hours
Sustained pain freedom at 24 hours	percentage of study participants who are pain free 24 hours after device use	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))	24 hours
Aura symptoms aborted after one use of device	yes/no	20 minutes
Side effects	Qualitative analysis	through study completion (1 to 10 months)
Adverse events	Qualitative analysis	through study completion (1 to 10 months)
Medicine use in 24 hours after device use	qualitative comparison	24 hours

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; Rehaler
• Investigators: Principal Investigator: Flemming W Bach, MD, PhD, Aarhus University Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 21, 2018

Study Record Updates

• Last Update Posted (Actual): March 23, 2018
• Last Update Submitted That Met QC Criteria: March 21, 2018
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Migraine with Aura
• Other Study ID Numbers: 2016-003683-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No