Partial Rebreathing in the Treatment of Migraine With Aura

NCT ID: NCT03472417

Last Updated: 2018-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-09-30

Brief Summary

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

Detailed Description

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Conditions

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Migraine With Aura

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Active partial rebreathing device

Group Type ACTIVE_COMPARATOR

Active partial rebreathing device

Intervention Type DEVICE

Dummy partial rebreathing device

Group Type SHAM_COMPARATOR

Dummy partial rebreathing device

Intervention Type DEVICE

Interventions

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Active partial rebreathing device

Intervention Type DEVICE

Dummy partial rebreathing device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Rehaler

INDUSTRY

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Flemming W Bach, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Pain and Headache Clinic, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 30134739 (View on PubMed)

Other Identifiers

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2016-003683-39

Identifier Type: -

Identifier Source: org_study_id

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