Transnasal Therapy for Acute Migraine Attack
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional

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.
    

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 of blood vessels has been postulated as a possible mechanism. 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 intra-nasal gas therapy is due to the cooling effect of dry
      gas on the nasal mucosa. Participants for this study are recruited from the pool of 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 the Johns Hopkins Bayview where 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 total sample size of 45 patients, 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 regular standards of care i.e., sooner. Participants will be reimbursed for
      participation in this study which will compensate travel and parking.
    

Intervention name(s): Humidified oxygen; Dry oxygen; Humidified air; Dry air
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Delivering humidified oxygen at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.; Delivering dry oxygen at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.; Delivering humidified air at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.; Delivering dry air at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Trans-nasal; acute; migraine