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Normobaric Oxygen (NBO) Therapy in Acute Migraine

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ClinicalTrials.gov Identifier: NCT01542307
Recruitment Status : Completed
First Posted : March 2, 2012
Results First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Aneesh B. Singhal, MD, Massachusetts General Hospital

February 21, 2012
March 2, 2012
October 16, 2016
March 27, 2017
March 27, 2017
July 2012
September 2015   (Final data collection date for primary outcome measure)
Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS) [ Time Frame: From baseline (0 minutes) to 30 mins ]

The mean change in VAS pain scores from 0 minutes to 30 minutes was selected as the primary outcome measure.

The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.

Change in Visual Analog Scale (VAS) from 0-30 minutes [ Time Frame: 30 mins ]
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.
Complete list of historical versions of study NCT01542307 on ClinicalTrials.gov Archive Site
  • Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS) [ Time Frame: Baseline (0 minutes) to 15 minutes ]

    The mean change in VAS pain scores from 0 minutes to 15 minutes was selected as a secondary outcome measure.

    The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.

  • Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS) [ Time Frame: Baseline (0 minutes) to 60 minutes ]

    The mean change in VAS pain scores from 0 minutes to 60 minutes was selected as a secondary outcome measure.

    The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.

  • Final Pain Severity Score 0-1 on the Visual Analogue Scale (VAS) [ Time Frame: 60 minutes ]

    The percentage of migraine attacks with the final (60 minute) VAS pain score 0-1 was selected as a secondary outcome measure.

    The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.

  • Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS) [ Time Frame: 60 minutes ]

    The percentage of migraine attacks with the final (60 minute) VAS pain score either 0-1, or a 3-point improvement from baseline, was selected as a secondary outcome measure.

    The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.

  • Final Visual Symptom Score 0-1 on the Visual Analog Scale (VAS) [ Time Frame: 60 minutes ]

    The percentage of migraine attacks with the final (60 minute) VAS visual symptom score 0-1 was selected as a secondary outcome measure.

    The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.

  • Final Nausea Score 0-1 on the Visual Analog Scale (VAS) [ Time Frame: 60 minutes ]

    The percentage of migraine attacks with the final (60 minute) VAS nausea score 0-1 was selected as a secondary outcome measure.

    The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.

Not Provided
Post-gas Therapy Medication Use [ Time Frame: 60 minutes ]
The percentage of migraine attacks requiring the use of one or more anti-migraine medications after the period of gas inhalation, was selected as a secondary outcome measure.
Not Provided
 
Normobaric Oxygen (NBO) Therapy in Acute Migraine
Normobaric Oxygen (NBO) Therapy in Acute Migraine
This is a pilot study investigating the therapeutic potential of breathing 100% oxygen in acute migraine headache.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Migraine
  • Biological: Oxygen
    Oxygen is inhaled for 30 minutes during migraine attack
  • Biological: Room air
    Placebo
  • Experimental: Oxygen
    Oxygen is inhaled for 30 minutes during migraine attack
    Intervention: Biological: Oxygen
  • Placebo Comparator: Room Air
    Medical air inhaled for 30 minutes during migraine attack
    Intervention: Biological: Room air
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
40
September 2015
September 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Secondary (non-migraine) headache
  • Chronic obstructive pulmonary disease
  • Pregnant
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01542307
2009P000380
2009P000380 ( Other Identifier: PHRC )
No
Not Provided
Plan to Share IPD: Undecided
Aneesh B. Singhal, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Aneesh B Singhal, MD Massachusetts General Hospital
Massachusetts General Hospital
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP