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Transnasal Therapy for Acute Migraine Attack

2019-10-23 13:11:56 | BioPortfolio

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 studies and shows to reduce headaches by reducing vasoconstriction. Some researchers have suggested cooling mechanism of oxygen as a possible mechanism. The main objective is to test the hypothesis that the pain relief obtained during high flow trans-nasal gas therapy is gas therapy is due to the cooling effect 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.

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. However, some researchers have proposed cooling effect as a possible mechanism. The main objective is to test the hypothesis that the pain relief obtained during high flow intranasal gas therapy is due to the cooling effect on the nasal mucosa. Patients for this study are recruited from the 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 Bayview where the 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 sample size of 45 patients in each arm, 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 if standards of care was started as usual, i.e., sooner. Participants will be reimbursed for participation in this study which will compensate travel and parking.

Study Design

Conditions

Migraine Disorders

Intervention

Humidified oxygen, Dry oxygen, Humidified air, Dry air

Location

Clinical Trials Unit, Johns Hopkins Bayview (JHU ICTR)
Baltimore
Maryland
United States
21224

Status

Recruiting

Source

Johns Hopkins University

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-23T13:11:56-0400

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Medical and Biotech [MESH] Definitions

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Unstable isotopes of oxygen that decay or disintegrate emitting radiation. O atoms with atomic weights 13, 14, 15, 19, and 20 are radioactive oxygen isotopes.

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