- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04129567
Transnasal Therapy for Acute Migraine Attack
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Migraine headaches are associated with significant impairment of quality of life and loss of productivity. High-flow oxygen has been successfully used in several clinical trials and vasoconstriction of blood vessels has been postulated as a possible mechanism. Some researchers have suggested that the cooling effect of high-flow dry oxygen may be in part responsible for the pain relief.The main objective is to test the hypothesis that the pain relief obtained during high-flow intra-nasal gas therapy is due to the cooling effect of dry gas on the nasal mucosa. Participants for this study are recruited from the pool of patients who are already scheduled to attend the headache clinic staffed by the principal investigator. The PI will recruit patients at the Headache Clinic. The patients are escorted to the Clinical Trials Unit (CTU) at the Johns Hopkins Bayview where therapy its provided and will be asked to fill out a questionnaire on pain, nausea, sound and light sensitivity using a visual analog score (VAS) for each symptom on a scale of 1-10. The patients will be randomized to either humidified oxygen, dry air, humidified air or dry oxygen. Patients will be asked to submit readings at the end of therapy, at 2 hours and 24 hours post-therapy. Treatment failure is defined as persistent headache despite treatment with oxygen or air. Participants will be removed from the trial if participants prematurely terminate therapy.
The investigators believe that using a total sample size of 45 patients, the investigators will be able to show a statistically significant difference of >2 point change in the VAS pain score reduction between the two treatment groups with a confidence of 80%. No risk were reported in prior studies involving >100 patients and >500 episodes of treatment with air or oxygen. Because of the (at least 2 and 1/2 hour) delay in initiating standard of care treatments, subjects may experience a longer duration and/or intensity of pain from the headache than regular standards of care i.e., sooner. Participants will be reimbursed for participation in this study which will compensate travel and parking.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21224
- Clinical Trials Unit, Johns Hopkins Bayview (JHU ICTR)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Migraine diagnosis of at least 1 year
- Migraine attacks between 1 and 15 per month
- Onset of first migraine < 50 years of age
- Migraine prophylaxis medication unchanged for 3 months prior to enrollment
- Meets international classification for headache disorders criteria for diagnosis of episodic migraine with or without aura
- Able to attend a short treatment session within half hour of onset of headache.
Exclusion Criteria:
- Known oxygen dependency to maintain arterial oxygen saturation (SaO2) >95%
- Known marked nasal septal deviation
- Recurrent epistaxis or chronic Rhino-Sinusitis
- Concurrent sinus/intranasal surgery
- Unable to fully understand the consent process and informed consent due to either language barriers or mental capacity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Humidified oxygen
Delivering humidified oxygen at 15 liters per minute through the nose and noting the change in primary and secondary outcome variables at 2 hours and 24 hours.
|
Delivering humidified oxygen at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.
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EXPERIMENTAL: Dry air
Delivering dry air at 15 liters per minute through the nose and noting the change in primary and secondary outcome variables at 2 hours and 24 hours.
|
Delivering dry air at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.
|
PLACEBO_COMPARATOR: Humidified air
Delivering humidified air at 15 liters per minute through the nose and noting the change in primary and secondary outcome variables at 2 hours and 24 hours.
|
Delivering humidified air at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.
|
ACTIVE_COMPARATOR: Dry oxygen
Delivering dry oxygen at 15 liters per minute through the nose and noting the change in primary and secondary outcome variables at 2 hours and 24 hours.
|
Delivering dry oxygen at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in pain score as assessed on the VAS scale
Time Frame: 2 hours and 24 hours
|
Graded on a scale of 1-10 where higher scores mean more pain.
|
2 hours and 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in nausea score as assessed on the VAS scale
Time Frame: 2 hours and 24 hours
|
Graded on a scale of 1-10 where higher scores mean more nausea.
|
2 hours and 24 hours
|
change in light sensitivity score as assessed on the VAS scale
Time Frame: 2 hours and 24 hours
|
Graded on a scale of 1-10 where higher scores mean more light sensitivity.
|
2 hours and 24 hours
|
change in sound sensitivity score as assessed on the VAS scale
Time Frame: 2 hours and 24 hours
|
Graded on a scale of 1-10 where higher scores mean more sound sensitivity.
|
2 hours and 24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nauman Tariq, MD, Johns Hopkins Neurology (Bayview)
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00166706
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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