Migraine With or Without AuraCALM3NCT06874361
Cooling to Alleviate Migraine #3
A study testing Mi-Helper in people with Migraine With or Without Aura and Migraine, run by Mi-Helper, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Migraine With or Without Aura, Migraine, Migraine Headache
- What is being tested?
- Mi-Helper
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2025to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 to 70 years, inclusive, of either sex at birth.
- Lives in the contiguous United States.
- Self-reported to be able to read and understand English sufficiently to provide electronic Informed Consent.
- Diagnosis of migraine with or without aura for at least 1 year.
- Individual experiences 2 to 8 migraine attacks per month documented via migraine eDiary during screening.
- Migraine onset before 50 years of age, self-reported during screening.
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- Migraine preventive medication unchanged for 4 weeks prior to study enrollment.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Individuals that own a functioning smartphone device, internet connection (Wi-Fi or data plan) and are willing to download the study app.
Who cannot join
- Participant has difficulty distinguishing his or her migraine attacks from other types of headaches such as tension, exertion, cluster, hormonal or sinus headaches.
- Participant has 15 or more headache days per month reported via migraine eDiary and during screening.
- Participant using any opioid medication at the time of screening.
- 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.
- Participant lives at an altitude of 2000 meters or more above sea level.
- Self-reported intolerance to intranasal therapy.
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- Self-reported recurrent epistaxis or chronic rhinosinusitis.
- Self-reported sinus or intranasal surgery within the last 4 months of screening.
- Self-reported history of 'complicated migraine or headaches' (i.e., hemiplegic migraine, ophthalmoplegic migraine, migrainous infarction, basilar migraine, post-traumatic headaches, post-concussion syndrome).
- Known or suspected pregnancy as self-reported by the prospective participant at the time of screening.
- Prospective participant unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity.
- Self-reported diagnosis of alcohol or substance abuse disorder at the time of screening.
- 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.
- Participant with severe uncontrolled psychiatric conditions or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments.
- 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.
- Participation in a previous clinical study with the Mi-Helper device.
- Participation in a migraine study or any other interventional clinical study within the3 months prior to screening.
- Participant has an uncontrolled medical issue at the time of screening.
- Any condition for which transnasal air flow would be contraindicated, as determined by the Principal Investigator (PI).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Migraine With or Without Aura, Migraine, Migraine Headache
- Being tested
- Mi-Helper
- Keywords
- Neuromodulation, Device, Neuromodulation device, Decentralized
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mi-HelperDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group I (active treatment) | Experimental | 10 liters per minute of dehumidified air administered via Mi-Helper for 15 minutes Receives: Device: Mi-Helper |
| Group II (sham) | Sham comparator | 2 LPM of ambient air administered intermittently via Mi-Helper for 15 minutes Receives: Device: Mi-Helper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Freedom at 2 Hours Post Treatment
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)
Measured: 2 hours
Secondary outcomes (4)
Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post Treatment
Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none at 2 hours post treatment completion.
Measured: 2 hours
Sustained Pain Freedom at 24 Hours Post Treatment
Proportion of participants with pain freedom with no administration of rescue medication and with no recurrence of a mild/moderate/severe headache
Measured: 2-24 Hours
Pain Relief at 2 Hours Post Treatment
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)
Measured: 2 hours
Participants' Global Impression of Acute Treatment Effect
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.
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start24 Mar 2025
- Primary completion29 Oct 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Migraine With or Without AuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mi-Helper, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jessica Ailani, MD, Principal investigator, MedStar Georgetown Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874361
- Sponsor's protocol ID
- COT-004
- Acronym
- CALM3
- Status last verified
- Jan 2026
- First submitted
- 5 Mar 2025
- Last updated
- 10 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06874361
- Acronym / sponsor ID
- CALM3 / COT-004
- Conditions
- Migraine With or Without Aura, Migraine, Migraine Headache
- Keywords
- Neuromodulation, Device, Neuromodulation device, Decentralized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Mi-Helper, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 29 Oct 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 13 Mar 2025 (actual)
- Results
- Posted 10 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (active treatment) | Experimental | Device: Mi-Helper10 liters per minute of dehumidified air administered via Mi-Helper for 15 minutes |
| Group II (sham) | Sham comparator | Device: Mi-Helper2 LPM of ambient air administered intermittently via Mi-Helper for 15 minutes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age of 18 to 70 years, inclusive, of either sex at birth.
- Lives in the contiguous United States.
- Self-reported to be able to read and understand English sufficiently to provide electronic Informed Consent.
- Diagnosis of migraine with or without aura for at least 1 year.
- Individual experiences 2 to 8 migraine attacks per month documented via migraine eDiary during screening.
Key exclusion criteria (19 listed)
- Participant has difficulty distinguishing his or her migraine attacks from other types of headaches such as tension, exertion, cluster, hormonal or sinus headaches.
- Participant has 15 or more headache days per month reported via migraine eDiary and during screening.
- Participant using any opioid medication at the time of screening.
- 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.
- Participant lives at an altitude of 2000 meters or more above sea level.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mi-HelperThe 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. | Device | Group I (active treatment), Group II (sham) |
Primary outcome
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)
4 secondary outcomes
Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post Treatment
Time frame: 2 hours
Sustained Pain Freedom at 24 Hours Post Treatment
Time frame: 2-24 Hours
Pain Relief at 2 Hours Post Treatment
Time frame: 2 hours
Participants' Global Impression of Acute Treatment Effect
Time frame: 24 Hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Ailani, MD principal investigator
MedStar Georgetown Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mi-Helper in people with Migraine With or Without Aura and Migraine, run by Mi-Helper, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Freedom at 2 Hours Post Treatment (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026; AzTrials last refreshed its copy on 31 Oct 2026.