Migraine
Conditions
Keywords
migraine, oxygen therapy
Brief summary
This is a pilot study investigating the therapeutic potential of breathing 100% oxygen in acute migraine headache.
Detailed 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.
Interventions
BIOLOGICALOxygen
Oxygen is inhaled for 30 minutes during migraine attack
BIOLOGICALRoom air
Placebo
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult subjects with frequent migraine (at least 1 attack per month)
Exclusion criteria
* Secondary (non-migraine) headache * Chronic obstructive pulmonary disease * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS) | 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) | 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) | 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 Visual Symptom Score 0-1 on the Visual Analog Scale (VAS) | 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) | 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. |
| Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post-gas Therapy Medication Use | 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. |
Countries
United States
Participant flow
Recruitment details
22 subjects enrolled
Pre-assignment details
22 subjects enrolled - each subject generated data for one or more migraine attacks.
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Subjects Oxygen or Medical Air is inhaled in random order for 30 minutes during each migraine attack (total 4 attacks) | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Enrolled Subjects |
|---|---|
| Age, Continuous | 36 years STANDARD_DEVIATION 10 |
| Anti-seizure meds for migraine prevention Not Using | 12 Participants |
| Anti-seizure meds for migraine prevention Using | 10 Participants |
| Beta-blockers for migraine prevention Not Using | 14 Participants |
| Beta-blockers for migraine prevention Using | 8 Participants |
| Education Level College or higher | 20 Participants |
| Education Level School or lower | 2 Participants |
| Employment Employed Full Time | 17 Participants |
| Employment Not Employed Full Time | 5 Participants |
| Family history of migraine Absent | 9 Participants |
| Family history of migraine Present | 13 Participants |
| Marital status Married | 10 Participants |
| Marital status Single | 12 Participants |
| Migraine Migraine w Aura | 7 Participants |
| Migraine Migraine without Aura | 15 Participants |
| NSAIDs/acetaminophen for acute migraine Not Using | 0 Participants |
| NSAIDs/acetaminophen for acute migraine Using | 22 Participants |
| One or more ED visits in prior year Not visited | 11 Participants |
| One or more ED visits in prior year Visited | 11 Participants |
| One or more lifetime ED visits None | 5 Participants |
| One or more lifetime ED visits Yes | 17 Participants |
| Opioids for acute migraine Not Using | 16 Participants |
| Opioids for acute migraine Using | 6 Participants |
| Race/Ethnicity, Customized Caucasian | 20 Participants |
| Race/Ethnicity, Customized Non-Caucasian | 2 Participants |
| Region of Enrollment United States | 22 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 2 Participants |
| Smoking Status Non-smoker | 20 Participants |
| Smoking Status Prior smoker | 2 Participants |
| Triptans for acute migraine Not Using | 4 Participants |
| Triptans for acute migraine Using | 18 Participants |
| Using botulinum toxin for migraine prevention Not Using | 18 Participants |
| Using botulinum toxin for migraine prevention Using | 4 Participants |
| Vascular risk factors (eg. hypertension) Absent | 20 Participants |
| Vascular risk factors (eg. hypertension) Present | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 22 | 2 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS)
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.
Time frame: From baseline (0 minutes) to 30 mins
Population: Number of migraine attacks treated with Oxygen or Medical Air
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxygen | Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS) | 1.38 units on a scale | Standard Deviation 1.42 |
| Room Air | Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS) | 1.22 units on a scale | Standard Deviation 1.61 |
p-value: 0.674Wilcoxon (Mann-Whitney)
Secondary
Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS)
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.
Time frame: Baseline (0 minutes) to 15 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxygen | Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS) | 0.77 units on a scale | Standard Deviation 1.09 |
| Room Air | Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS) | 0.44 units on a scale | Standard Deviation 0.92 |
p-value: 0.18Wilcoxon (Mann-Whitney)
Secondary
Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS)
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.
Time frame: Baseline (0 minutes) to 60 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxygen | Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS) | 2.05 units on a scale | Standard Deviation 2.23 |
| Room Air | Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS) | 1.57 units on a scale | Standard Deviation 1.94 |
p-value: 0.38Wilcoxon (Mann-Whitney)
Secondary
Final Nausea Score 0-1 on the Visual Analog Scale (VAS)
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.
Time frame: 60 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oxygen | Final Nausea Score 0-1 on the Visual Analog Scale (VAS) | 64 percentage of attacks |
| Room Air | Final Nausea Score 0-1 on the Visual Analog Scale (VAS) | 65 percentage of attacks |
p-value: 1Fisher Exact
Secondary
Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS)
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.
Time frame: 60 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oxygen | Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS) | 45 percentage of attacks |
| Room Air | Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS) | 23 percentage of attacks |
p-value: 0.05Fisher Exact
Secondary
Final Pain Severity Score 0-1 on the Visual Analogue Scale (VAS)
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.
Time frame: 60 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oxygen | Final Pain Severity Score 0-1 on the Visual Analogue Scale (VAS) | 24 percentage of attacks |
| Room Air | Final Pain Severity Score 0-1 on the Visual Analogue Scale (VAS) | 6 percentage of attacks |
p-value: 0.05Fisher Exact
Secondary
Final Visual Symptom Score 0-1 on the Visual Analog Scale (VAS)
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.
Time frame: 60 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oxygen | Final Visual Symptom Score 0-1 on the Visual Analog Scale (VAS) | 36 percentage of attacks |
| Room Air | Final Visual Symptom Score 0-1 on the Visual Analog Scale (VAS) | 6 percentage of attacks |
p-value: 0.004Fisher Exact
Other Pre-specified
Post-gas Therapy Medication Use
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.
Time frame: 60 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oxygen | Post-gas Therapy Medication Use | 36 percentage of attacks |
| Room Air | Post-gas Therapy Medication Use | 52 percentage of attacks |
p-value: 0.16Fisher Exact