Cooling to Alleviate Migraine #3

Part of paid clinical trials in Indian Harbour Beach, Florida.

Sponsor
Mi-Helper, Inc.
Study ID
NCT06874361
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Mi-Helper — 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.

Study Details

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.

Key Dates

Start date
Mar 24, 2025
Status verified
Jan 2026
Primary completion
Oct 29, 2025
Completion
Dec 15, 2025

Study Design

Enrollment
156 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group I (active treatment)
    10 liters per minute of dehumidified air administered via Mi-Helper for 15 minutes
  • Sham Comparator: Group II (sham)
    2 LPM of ambient air administered intermittently via Mi-Helper for 15 minutes

Primary Outcome Measure

Pain Freedom at 2 Hours Post Treatment [ Time Frame: 2 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
SPRIM ProIndian Harbour BeachFlorida32937-

Find similar trials in Indian Harbour Beach, FL

By condition
Migraine
By specialty
Neurology
By research site
SPRIM Pro· Indian Harbour Beach, FL

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