Normobaric Oxygen (NBO) Therapy in Acute Migraine

Migraine Clinical Trial

Official title:

Normobaric Oxygen (NBO) Therapy in Acute Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01542307
• Other study ID #: 2009P000380
• Secondary ID: 2009P000380
• Status: Completed
• Phase: Phase 2
• First received: February 21, 2012
• Last updated: October 11, 2016
• Start date: July 2012
• Est. completion date: September 2015

Study information

• Verified date: October 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Secondary (non-migraine) headache

• Chronic obstructive pulmonary disease

• Pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Biological:
• Oxygen
Oxygen is inhaled for 30 minutes during migraine attack
• Room air
Placebo

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. 2016 May 20. pii: 0333102416651453. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visual Analog Scale (VAS) from 0-30 minutes	Subjects will complete the VAS at 0 minutes, 15 minutes, 30 minutes and 60 minutes after starting gas therapy. The mean change in VAS scores from 0 minutes to 30 minutes will be the primary outcome measure.	30 mins	No