NCT06051604

Mi-Helper Transnasal Cooling for Acute Treatment of Migraine

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: CoolTech LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

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: 2023-11-15
• Primary completion: 2024-06-18
• Completion: 2024-09-24
• First posted: 2023-09-25
• Last updated: 2024-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study