An interventional study of Mi-Helper in Episodic Migraine, Migraine With Aura and Migraine Without Aura, sponsored by CoolTech LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-09-26.
Sponsored by CoolTech LLC · Not applicable, Interventional, and Treatment
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 172 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →CoolTech LLC is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2 LPM of ambient air administered intermittently via Mi-Helper for 15 minutes
Device: Mi-Helper
4 LPM of dehumidified air administered via Mi-Helper for 15 minutes
Device: Mi-Helper
6 LPM of dehumidified air administered via Mi-Helper for 15 minutes
Device: Mi-Helper
10 LPM of dehumidified air administered via Mi-Helper for 15 minutes
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.
Also known as: Mi-Helper transnasal cooling device
Pain relief at 2 hours post treatment
From severe or moderate to mild or no pain, or from mild to no pain; based on the traditional 4-point VRS scale
Time frame: 2 hours
Safety of the Mi-Helper device
Measured by incidence of adverse events
Time frame: 24 hours
Tolerability of the Mi-Helper device
Based on percent of participants who fail to complete the full treatment session
Time frame: 15 minutes
Pain relief immediately post treatment
From severe or moderate to mild or no pain, or from mild to no pain; based on the traditional 4-point VRS scale
Time frame: 0 minutes
Pain relief at 24 hours post treatment
From severe or moderate to mild or no pain, or from mild to no pain; based on the traditional 4-point VRS scale
Time frame: 24 hours
Pain freedom immediately post treatment
A reduction of mild, moderate or severe pain at baseline to no pain.
Time frame: 0 minutes
Pain freedom at 2 hours post treatment
A reduction of mild, moderate or severe pain at baseline to no pain.
Time frame: 2 hours
Pain freedom at 24 hours post treatment
A reduction of mild, moderate or severe pain at baseline to no pain.
Time frame: 24 hours
Relief from most bothersome symptom (MBS) immediately post treatment
From severe or moderate to mild or none, or from mild to none; based on the traditional 4-point VRS scale
Time frame: 0 minutes
Relief from MBS at 2 hours post treatment
From severe or moderate to mild or none, or from mild to none; based on the traditional 4-point VRS scale
Time frame: 2 hours
Relief from MBS at 24 hours post treatment
From severe or moderate to mild or none, or from mild to none; based on the traditional 4-point VRS scale
Time frame: 24 hours
Freedom from MBS immediately post treatment
A reduction of mild, moderate or severe pain at baseline to none.
Time frame: 0 minutes
Freedom from MBS at 2 hours post treatment
A reduction of mild, moderate or severe pain at baseline to none.
Time frame: 2 hours
Freedom from MBS at 24 hours post treatment
A reduction of mild, moderate or severe pain at baseline to none.
Time frame: 24 hours
Use of rescue medication 2-24 post treatment.
Time frame: 24 hours
Participants belief of which treatment is received.
Time frame: 24 hours
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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