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Transnasal Therapy for Acute Migraine Attack

NCT04129567 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2020-07-17

No results posted yet for this study

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. 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.

Conditions

  • Migraine Disorders

Interventions

OTHER

Humidified oxygen

Delivering humidified oxygen at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.

OTHER

Dry oxygen

Delivering dry oxygen at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.

OTHER

Humidified air

Delivering humidified air at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.

OTHER

Dry air

Delivering dry air at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.

Sponsors & Collaborators

Principal Investigators

  • Nauman Tariq, MD · Johns Hopkins Neurology (Bayview)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-15
Primary Completion
2019-10-31
Completion
2019-11-15

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04129567 on ClinicalTrials.gov