Partial Rebreathing in the Treatment of Migraine With Aura

Not Applicable

Completed

• Conditions: Migraine With Aura
• Interventions: Device: Dummy partial rebreathing device; Device: Active partial rebreathing device

• Registration Number: NCT03472417
• Lead Sponsor: University of Aarhus

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2017-05-02
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Study First Submitted QC: 2018-03-20
• Study First Posted: 2018-03-21
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dummy partial rebreathing device	Dummy partial rebreathing device	-
Active partial rebreathing device	Active partial rebreathing device	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pain and Headache Clinic, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark