NCT06874361

Cooling to Alleviate Migraine #3

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Mi-Helper, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-24
• Primary completion: 2025-10-29
• Completion: 2025-12-15
• First posted: 2025-03-13
• Last updated: 2026-02-10
• Results posted: 2026-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study