Migraine Disorders Clinical Trial
Official title:
Transnasal Therapy for Acute Migraine Attack
Verified date | July 2020 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 51 |
Est. completion date | November 15, 2019 |
Est. primary completion date | October 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Clinical Trials Unit, Johns Hopkins Bayview (JHU ICTR) | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in pain score as assessed on the VAS scale | Graded on a scale of 1-10 where higher scores mean more pain. | 2 hours and 24 hours | |
Secondary | change in nausea score as assessed on the VAS scale | Graded on a scale of 1-10 where higher scores mean more nausea. | 2 hours and 24 hours | |
Secondary | change in light sensitivity score as assessed on the VAS scale | Graded on a scale of 1-10 where higher scores mean more light sensitivity. | 2 hours and 24 hours | |
Secondary | change in sound sensitivity score as assessed on the VAS scale | Graded on a scale of 1-10 where higher scores mean more sound sensitivity. | 2 hours and 24 hours |
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