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Transnasal Cooling for Migraine | Clinical Trials | Clareo Health

TERMINATEDNA

Transnasal Cooling for Migraine

A Transnasal Evaporative Cooling Device for Acute Treatment of Migraine

NCT04936061•CoolTech LLC

Summary

This is a prospective, double-blind, sham-controlled, randomized study to assess the safety, tolerability, and optimal dose of the COOLSTAT Transnasal Thermal Regulating Device for acute treatment of migraine. The hypothesis is that evaporative cooling induced by the CoolStat using only ambient, dry air will reduce the pain and other symptoms of migraine headaches during an acute migraine episode.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Meets the International Classification of Headache Disorders (ICHD-3) diagnostic criteria for migraine with or without aura, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, ophthalmoplegic migraine, migrainous infarction).
•2. Patient is between 18 and 80 years of age.
•3. Patient experiences 2 to 8 migraine attacks per month.
•4. Patient is in good reported general health, with no fever (\<38.3C/101F).
•5. Patient has had diagnosis of migraine with or without aura over at least 1 year.
•6. Migraine onset before 50 years of age.
•7. Migraine prophylaxis medication unchanged for 6 weeks prior to study enrollment.
•8. Able to attend treatment session within 6 hours of migraine onset, with 48 hours of pain freedom prior to onset of migraine attack.
•9. Migraine pain severity of Grade 2 or Grade 3 on day of treatment.
•10. Provision of signed and dated informed consent form.
+1 more criteria

Exclusion Criteria

•1. has difficulty distinguishing his or her migraine attacks from tension-type headaches
•2. Patient has uncontrolled hypertension.
•3. Patient has a fever (≥38.3C / 101F).
•4. Patient has used opioid medication or barbiturates in the past month.
•5. Patient has Medication Overuse Headache (MOH), New Daily Persistent Headache (NDPH) or Chronic Tension Type Headache (CTTH).
•6. Patient has 15 or more headache days per month.
•7. Patient has used acute treatment(s) for migraine in the 48 hours preceding treatment i.e. over-the-counter (OTC) medications, prescription medications, or medical device).
•8. Patient has received Botox treatment, supraorbital or occipital nerve blocks in the last 4 weeks.
•9. Intolerance to intranasal neurostimulation or sensory processing disorder that makes the treatment not applicable.
•10. Recurrent epistaxis or chronic rhinosinusitis.
+3 more criteria

Locations (3)

Mayo Clinic

Scottsdale, Arizona, United States

Michigan State University

East Lansing, Michigan, United States

Atrium Health Neurosciences Institute

Charlotte, North Carolina, United States

Key Dates

Start Date

October 14, 2021

Primary Completion Date

August 31, 2022

Completion Date

September 30, 2022

Last Updated

September 29, 2023

Enrollment

ACTUAL participants

Conditions

MigraineEpisodic MigraineMigraine With AuraMigraine Without Aura

Interventions

CoolStat active device

DEVICE

CoolStat sham device

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 29, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Transnasal Cooling for Migraine

Inclusion Criteria

Exclusion Criteria

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

Mind Body Balance for Pediatric Migraine

Light Exposure, Migraine Outcomes, and Sleep Quality

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

Prophylactic Treatment With Atorvastatin for Episodic Migraine.