Mi-Helper Transnasal Cooling for Acute Treatment of Migraine

NCT ID: NCT06051604

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2024-09-24

Brief Summary

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

Adults aged 18 years to 65 years old with a diagnosis of episodic migraine (with or without aura) for at least one year (self-reported) will be recruited for this study.

Conditions

Episodic Migraine; Migraine With Aura; Migraine Without Aura; Migraine

Study Design

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

Study Groups

Group I (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.

Group II (active treatment 1)

4 LPM 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 III (active treatment 2)

6 LPM 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 IV (active treatment 3)

10 LPM 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.

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

Other Intervention Names

Mi-Helper transnasal cooling device

Eligibility Criteria

Inclusion Criteria

1. Age of 18 to 65 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 informed consent.

4. Individual has had a diagnosis of episodic migraine with or without aura over at least 1 year, self-reported during screening.

5. Individual experiences 2 to 8 migraine attacks per month documented via migraine eDiary during screening.

6. Individual is in good reported general health at the time of screening.

7. Migraine onset before 50 years of age, self-reported during screening.

8. Migraine prophylaxis medication unchanged for 4 weeks prior to study enrollment.

9. Stated willingness to comply with all study procedures and availability for the duration of the study.

10. 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 tension-type 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, supraorbital or occipital nerve blocks 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 psychiatric conditions (such as major depressive episode, bipolar disorder, major depressive disorder, schizophrenia), dementia, 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. Prospective participant has participated in a migraine study or any interventional clinical study within the 6 months prior to screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ObvioHealth

INDUSTRY

Sponsor Role: collaborator

CoolTech LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Parth Shah, MD

Role: PRINCIPAL_INVESTIGATOR

ObvioHealth

Locations

ObvioHealth

New York, New York, United States

Countries

United States

Other Identifiers

COT-001

Identifier Type: -

Identifier Source: org_study_id