Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT03167060
Eligibility Criteria:
Inclusion Criteria:
* 18 Years old or over and ≤70 years of age.
* 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 (2nd Edition) criteria for diagnosis of Episodic Migraine with or without aura
* Able to attend a short training session on the practical use of the RhinoChill® device and agrees to only use the device as instructed and as laid out in the official instructions for use
Exclusion Criteria:
* \< 18 and \>70 years of age
* Known oxygen dependency to maintain SaO2 \>95%
* Diagnosed Hypertensive and currently uncontrolled with Systolic BP \> 140mmHg and Diastolic BP \> 90mmHg on baseline assessment.
* Marked nasal septal deviation, recurrent epistaxis or chronic Rhino-Sinusitis.
* Intranasal obstruction preventing full insertion of nasal catheter.
* Known base of skull fracture or facial trauma
* Concurrent sinus/intranasal surgery
* Diagnosed with Thromobocytopenia
* Previous Stroke or Myocardial Infarction
* Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity
* Previously enrolled into the COOLHEAD 1 trial.
* No recorded migraine following initial 30 day data collection period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03167060
Study Brief:
Protocol Section:
NCT03167060