Cooling to Alleviate Migraine #3 (CALM3)

January 22, 2026 updated by: Mi-Helper, Inc.

A Prospective, Double-blind, Sham-controlled, Randomized Clinical Trial to Assess the Safety and Efficacy of the Mi-Helper Device for Acute Treatment of Migraine in an At Home Setting.

This is a prospective, double-blind, sham-controlled, randomized, decentralized trial. This study aims to assess the safety and efficacy of the Mi-Helper transnasal cooling device for acute treatment of migraine in an at home setting.

Adults aged 18 years to 70 years old with a diagnosis of migraine (with or without aura) for at least one year will be recruited for this study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Indian Harbour Beach, Florida, United States, 32937
        • SPRIM Pro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age of 18 to 70 years, inclusive, of either sex at birth.
  2. Lives in the contiguous United States.
  3. Self-reported to be able to read and understand English sufficiently to provide electronic Informed Consent.
  4. Diagnosis of migraine with or without aura for at least 1 year.
  5. Individual experiences 2 to 8 migraine attacks per month documented via migraine eDiary during screening.
  6. Migraine onset before 50 years of age, self-reported during screening.
  7. Migraine preventive medication unchanged for 4 weeks prior to study enrollment.
  8. Stated willingness to comply with all study procedures and availability for the duration of the study.
  9. Individuals that own a functioning smartphone device, internet connection (Wi-Fi or data plan) and are willing to download the study app.

Exclusion Criteria:

  1. Participant has difficulty distinguishing his or her migraine attacks from other types of headaches such as tension, exertion, cluster, hormonal or sinus headaches.
  2. Participant has 15 or more headache days per month reported via migraine eDiary and during screening.
  3. Participant using any opioid medication at the time of screening.
  4. Participant has received Botox treatment, barbiturates, SPG block, nerve blocks or trigger point injections in the head or neck within the last 4 weeks of screening.
  5. Participant lives at an altitude of 2000 meters or more above sea level.
  6. Self-reported intolerance to intranasal therapy.
  7. Self-reported recurrent epistaxis or chronic rhinosinusitis.
  8. Self-reported sinus or intranasal surgery within the last 4 months of screening.
  9. Self-reported history of 'complicated migraine or headaches' (i.e., hemiplegic migraine, ophthalmoplegic migraine, migrainous infarction, basilar migraine, post-traumatic headaches, post-concussion syndrome).
  10. Known or suspected pregnancy as self-reported by the prospective participant at the time of screening.
  11. Prospective participant unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity.
  12. Self-reported diagnosis of alcohol or substance abuse disorder at the time of screening.
  13. Participant with active chronic pain syndromes, such as fibromyalgia, chronic pelvic pain, or Complex Regional Pain Syndrome (CRPS); or other pain syndrome like trigeminal neuralgia.
  14. Participant with severe uncontrolled psychiatric conditions or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments.
  15. Failure to adhere to or inability to complete Study App inputs and onboarding activities during the screening period. Participants who are not adherent during the screening period are not eligible for study entry.
  16. Participation in a previous clinical study with the Mi-Helper device.
  17. Participation in a migraine study or any other interventional clinical study within the3 months prior to screening.
  18. Participant has an uncontrolled medical issue at the time of screening.
  19. Any condition for which transnasal air flow would be contraindicated, as determined by the Principal Investigator (PI).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group I (active treatment)
10 liters per minute of dehumidified air administered via Mi-Helper for 15 minutes
Device: Mi-Helper
The Mi-Helper device is a non-invasive, drug-free, novel therapy that uses a patented process of dry air flow across the nasal turbinates to induce a phase change (evaporation) that extracts energy (thermodynamics) causing local cooling which modulates nerves associated with pain and other symptoms of migraine. The device delivers a controlled pressure and flow of dry room temperature air along with a nebulized saline mist for added comfort and evaporative efficiency.
Sham Comparator: Group II (sham)
2 LPM of ambient air administered intermittently via Mi-Helper for 15 minutes
Device: Mi-Helper
The Mi-Helper device is a non-invasive, drug-free, novel therapy that uses a patented process of dry air flow across the nasal turbinates to induce a phase change (evaporation) that extracts energy (thermodynamics) causing local cooling which modulates nerves associated with pain and other symptoms of migraine. The device delivers a controlled pressure and flow of dry room temperature air along with a nebulized saline mist for added comfort and evaporative efficiency.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Freedom at 2 Hours Post Treatment
Time Frame: 2 hours
Proportion of participants with a change in headache severity from mild/moderate/severe pain at baseline to no pain at 2 hours after treatment completion (if rescue medication was not used)
2 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Relief at 2 Hours Post Treatment
Time Frame: 2 hours
Proportion of participants with a change in headache severity from severe or moderate pain at baseline to mild or no pain at 2 hours post treatment completion, or from mild pain at baseline to no pain no pain at 2 hours after treatment completion (if rescue medication was not used)
2 hours
Sustained Pain Freedom at 24 Hours Post Treatment
Time Frame: 2-24 Hours
Proportion of participants with pain freedom with no administration of rescue medication and with no recurrence of a mild/moderate/severe headache
2-24 Hours
Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post Treatment
Time Frame: 2 hours
Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none at 2 hours post treatment completion.
2 hours
Participants' Global Impression of Acute Treatment Effect
Time Frame: 24 Hours
Measured by the Patient Global Impression of Change (PGIC), on which participants use a 7-point scale, where 1=very much improved to 7=very much worse. Scores of 1 or 2 will be considered successes.
24 Hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Relief Immediately Post Treatment
Time Frame: 0 minutes
Proportion of participants with a change in headache severity from severe or moderate pain at baseline to mild or no pain at 0 hours post treatment completion, or from mild pain at baseline to no pain no pain at 0 hours after treatment completion (if rescue medication was not used)
0 minutes
Pain Freedom Immediately Post Treatment
Time Frame: 0 Hours
Proportion of participants with a change in headache severity from mild/moderate/severe pain at baseline to no pain at 2 hours after treatment completion (if rescue medication was not used)
0 Hours
Sustained Pain Freedom at 48 Hours Post Treatment
Time Frame: 2 - 48 Hours
Proportion of participants with pain freedom with no administration of rescue medication and with no recurrence of a mild/moderate/severe headache
2 - 48 Hours
Rescue Medication Use
Time Frame: 2 Hours
Use of rescue medication before 2 hours post treatment completion.
2 Hours
Freedom From Most Bothersome Symptom (MBS) at Immediately Post Treatment
Time Frame: 0 minutes
Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none immediately post treatment completion.
0 minutes
Relief From Most Bothersome Symptom (MBS) Immediately Post Treatment
Time Frame: 0 hours
Proportion of participants with a change from severe or moderate symptom severity at baseline to the traditional 4-point Visual Rating Scalemild or none at 0 hours, or from mild symptom severity at baseline to none at 0 hours post treatment completion (based on the traditional 4-point Visual Rating Scale)
0 hours
Freedom From Nausea Immediately Post Treatment
Time Frame: 0 hours
Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none immediately post treatment completion (based on the traditional 4-point Visual Rating Scale)
0 hours
Freedom From Photophobia Immediately Post Treatment
Time Frame: 0 Hours
Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none ( immediately post treatment completion.
0 Hours
Freedom From Phonophobia Immediately Post Treatment
Time Frame: 0 hours
Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none immediately post treatment completion.
0 hours
Freedom From Nausea at 2 Hours Post Treatment
Time Frame: 2 Hours
A reduction from mild, moderate or severe symptom severity at baseline to none at 2 hours post treatment completion.
2 Hours
Freedom From Photophobia at 2 Hours Post Treatment
Time Frame: 2 Hours
Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none at 2 hours post treatment completion.
2 Hours
Freedom From Phonophobia at 2 Hours Post Treatment
Time Frame: 2 Hours
Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none at 2 hours post treatment completion.
2 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mi-Helper, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jessica Ailani, MD, MedStar Georgetown Headache Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 24, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 29, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COT-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in the final article including results in the text, tables, figures, and appendices, will be made available after deidentification.

IPD Sharing Time Frame

The data will be made available within 6 months of the study's conclusion and will remain available for at least 3 years.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal to achieve results in line with the proposed outcomes will be able to obtain IPD.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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