Cooling to Alleviate Migraine #3

NCT ID: NCT06874361

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-24
• Study Completion Date: 2025-12-15

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group I (active treatment)

10 liters per minute of dehumidified air administered via Mi-Helper for 15 minutes

Group Type: EXPERIMENTAL

Mi-Helper

Intervention Type: DEVICE

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.

Group II (sham)

2 LPM of ambient air administered intermittently via Mi-Helper for 15 minutes

Group Type: SHAM_COMPARATOR

Mi-Helper

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mi-Helper, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Ailani, MD

Role: PRINCIPAL_INVESTIGATOR

MedStar Georgetown Headache Center

Locations

SPRIM Pro

Indian Harbour Beach, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

COT-004

Identifier Type: -

Identifier Source: org_study_id