Partial Rebreathing in the Treatment of Migraine With Aura

Migraine With Aura Clinical Trial

— CapnoMigra  

Official title:

Partial Rebreathing in the Treatment of Migraine With Aura

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03472417
• Other study ID #: 2016-003683-39
• Status: Completed
• Phase: N/A
• First received: May 2, 2017
• Last updated: March 21, 2018
• Start date: November 2016
• Est. completion date: September 2017

Study information

• Verified date: November 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine with Aura

Intervention

Device:
• Active partial rebreathing device

• Dummy partial rebreathing device

Locations

Country	Name	City	State
Denmark	Pain and Headache Clinic, Aarhus University Hospital	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, BalancAir

Country where clinical trial is conducted

Denmark, 

Outcome

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