Normobaric Oxygen (NBO) Therapy in Acute Migraine

NCT ID: NCT01542307

Last Updated: 2017-03-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-09-30

Brief Summary

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This is a pilot study investigating the therapeutic potential of breathing 100% oxygen in acute migraine headache.

Detailed Description

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A total of 40 adult subjects will be enrolled, male and female. Subjects will be consented to inhale either Normobaric Oxygen (NBO) or Room air for 30 minutes at the start of their migraine attacks. Outcomes will be assessed during and after gas treatment.

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Oxygen

Oxygen is inhaled for 30 minutes during migraine attack

Group Type EXPERIMENTAL

Oxygen

Intervention Type BIOLOGICAL

Oxygen is inhaled for 30 minutes during migraine attack

Room Air

Medical air inhaled for 30 minutes during migraine attack

Group Type PLACEBO_COMPARATOR

Room air

Intervention Type BIOLOGICAL

Placebo

Interventions

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Oxygen

Oxygen is inhaled for 30 minutes during migraine attack

Intervention Type BIOLOGICAL

Room air

Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Adult subjects with frequent migraine (at least 1 attack per month)

Exclusion Criteria

* Secondary (non-migraine) headache
* Chronic obstructive pulmonary disease
* Pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Aneesh B. Singhal, MD

Associate Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aneesh B Singhal, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Singhal AB, Maas MB, Goldstein JN, Mills BB, Chen DW, Ayata C, Kacmarek RM, Topcuoglu MA. High-flow oxygen therapy for treatment of acute migraine: A randomized crossover trial. Cephalalgia. 2017 Jul;37(8):730-736. doi: 10.1177/0333102416651453. Epub 2016 May 20.

Reference Type RESULT
PMID: 27206964 (View on PubMed)

Other Identifiers

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2009P000380

Identifier Type: OTHER

Identifier Source: secondary_id

2009P000380

Identifier Type: -

Identifier Source: org_study_id

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