Status:
COMPLETED
Transnasal Therapy for Acute Migraine Attack
Lead Sponsor:
Johns Hopkins University
Conditions:
Migraine Disorders
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Migraine is a significant health problem in the United States with 34 million Americans suffering from migraine attacks every year. High-flow oxygen has been successfully used in several clinical stud...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2019
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04129567
Start Date
August 15 2018
End Date
November 15 2019
Last Update
July 17 2020
Active Locations (1)
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1
Clinical Trials Unit, Johns Hopkins Bayview (JHU ICTR)
Baltimore, Maryland, United States, 21224