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| ID | Type | Description | Link |
|---|---|---|---|
| 2009P000380 | Other Identifier | PHRC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxygen | Experimental | Oxygen is inhaled for 30 minutes during migraine attack |
|
| Room Air | Placebo Comparator | Medical air inhaled for 30 minutes during migraine attack |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen | Biological | Oxygen is inhaled for 30 minutes during migraine attack |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline (0 minutes) to 30 mins |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (0 minutes) to 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 60 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aneesh B Singhal, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27206964 | Result | 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. |
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22 subjects enrolled - each subject generated data for one or more migraine attacks.
22 subjects enrolled
| ID | Title | Description |
|---|---|---|
| FG000 | Oxygen-treated Migraine Attacks | Oxygen is inhaled for 30 minutes during a migraine attack |
| FG001 | Medical Air-treated Migraine Attacks | Medical air is inhaled for 30 minutes during a migraine attack |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Enrolled subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled Subjects | Oxygen or Medical Air is inhaled in random order for 30 minutes during each migraine attack (total 4 attacks) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number of migraine attacks treated with Oxygen or Medical Air | Posted | Mean | Standard Deviation | units on a scale | From baseline (0 minutes) to 30 mins | Migraine attacks | Migraine attacks |
|
Adverse events were collected from the time of enrollment and until a maximum of 4 migraine attacks were treated with gas inhalation and study equipment returned to the study team.
Specific adverse events ('events of interest') were monitored around the time of each migraine attack (individual subjects had 1-4 migraine attacks each).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxygen | Oxygen is inhaled for 30 minutes during migraine attack Oxygen: Oxygen is inhaled for 30 minutes during migraine attack |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aneesh Singhal, MD | Massachusetts General Hospital | 6177268459 | 4 | asinghal@partners.org |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| Room air |
| Biological |
Placebo |
|
| 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. |
| Baseline (0 minutes) to 60 minutes |
| 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. | 60 minutes |
| 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. | 60 minutes |
| 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. | 60 minutes |
| 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. | 60 minutes |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Migraine | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
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| Education Level | Count of Participants | Participants |
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| Marital status | Count of Participants | Participants |
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| Smoking Status | Count of Participants | Participants |
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| Family history of migraine | Count of Participants | Participants |
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| Vascular risk factors (eg. hypertension) | Count of Participants | Participants |
|
| One or more lifetime ED visits | Count of Participants | Participants |
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| One or more ED visits in prior year | Count of Participants | Participants |
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| Triptans for acute migraine | Count of Participants | Participants |
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| NSAIDs/acetaminophen for acute migraine | Count of Participants | Participants |
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| Opioids for acute migraine | Count of Participants | Participants |
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| Anti-seizure meds for migraine prevention | Count of Participants | Participants |
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| Beta-blockers for migraine prevention | Count of Participants | Participants |
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| Using botulinum toxin for migraine prevention | Count of Participants | Participants |
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|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline (0 minutes) to 15 minutes | Migraine attacks | Migraine attacks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline (0 minutes) to 60 minutes | Migraine attacks | Migraine attacks |
|
|
|
|
| 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. | Posted | Number | percentage of attacks | 60 minutes | Migraine attacks | Migraine attacks |
|
|
|
|
| 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. | Posted | Number | percentage of attacks | 60 minutes | Migraine attacks | Migraine attacks |
|
|
|
|
| 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. | Posted | Number | percentage of attacks | 60 minutes | Migraine attacks | Migraine attacks |
|
|
|
|
| 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. | Posted | Number | percentage of attacks | 60 minutes | Migraine attacks | Migraine attacks |
|
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|
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| 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. | Posted | Number | percentage of attacks | 60 minutes | Migraine attacks | Migraine attacks |
|
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|
|
| 0 |
| 22 |
| 2 |
| 22 |
| EG001 | Room Air | Medical air inhaled for 30 minutes during migraine attack Room air: Placebo | 0 | 22 | 2 | 22 |
| Tingling | Nervous system disorders | Systematic Assessment |
|
| Significant worsening of migraine headache | Nervous system disorders | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |