Transnasal Therapy for Acute Migraine Attack

Completed · Not applicable

Conditions studied: Migraine Disorders

In brief

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 studies. Vasoconstriction of blood vessels in the scalp has been proposed as a possible mechanism of action. 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 trans-nasal gas therapy is due to the cooling effect of dry gas on the nasal mucosa. The study entails recruiting patients from a headache clinic, being escorted to the Institute for Clinical and Translational Research (ICTR) Johns Hopkins Bayview and randomized into different groups (humidified oxygen, dry air, humidified air and dry oxygen). Eventually, patients will be asked to fill out a questionnaire on pain, nausea, sound and light sensitivity graded on a scale of 1-10. Readings are noted at baseline, 15 mins, 2 hours and 24 hours post-therapy.

Key facts

Study ID

NCT04129567

Run by

Johns Hopkins University

People needed

51

Starts

2018-08-15

Expected to finish

2019-11-15

Last updated by the study team

2020-07-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Trials Unit, Johns Hopkins Bayview (JHU ICTR) — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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