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.
1 other identifier
interventional
172
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2023
CompletedFirst Posted
Study publicly available on registry
September 25, 2023
CompletedStudy Start
First participant enrolled
November 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 24, 2024
CompletedSeptember 26, 2024
September 1, 2024
7 months
September 18, 2023
September 25, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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
2 hours
Safety of the Mi-Helper device
Measured by incidence of adverse events
24 hours
Tolerability of the Mi-Helper device
Based on percent of participants who fail to complete the full treatment session
15 minutes
Secondary Outcomes (11)
Pain relief immediately post treatment
0 minutes
Pain relief at 24 hours post treatment
24 hours
Pain freedom immediately post treatment
0 minutes
Pain freedom at 2 hours post treatment
2 hours
Pain freedom at 24 hours post treatment
24 hours
- +6 more secondary outcomes
Other Outcomes (2)
Use of rescue medication 2-24 post treatment.
24 hours
Participants belief of which treatment is received.
24 hours
Study Arms (4)
Group I (sham)
SHAM COMPARATOR2 LPM of ambient air administered intermittently via Mi-Helper for 15 minutes
Group II (active treatment 1)
EXPERIMENTAL4 LPM of dehumidified air administered via Mi-Helper for 15 minutes
Group III (active treatment 2)
EXPERIMENTAL6 LPM of dehumidified air administered via Mi-Helper for 15 minutes
Group IV (active treatment 3)
EXPERIMENTAL10 LPM of dehumidified air administered via Mi-Helper for 15 minutes
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age of 18 to 65 years, inclusive of either sex at birth.
- Lives in the contiguous United States.
- Self-reported to be able to read and understand English sufficiently to provide informed consent.
- Individual has had a diagnosis of episodic migraine with or without aura over at least 1 year, self-reported during screening.
- Individual experiences 2 to 8 migraine attacks per month documented via migraine eDiary during screening.
- Individual is in good reported general health at the time of screening.
- Migraine onset before 50 years of age, self-reported during screening.
- Migraine prophylaxis medication unchanged for 4 weeks prior to study enrollment.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Individuals that own a functioning smartphone device, internet connection (Wi-Fi or data plan) and are willing to download the study app.
You may not qualify if:
- Participant has difficulty distinguishing his or her migraine attacks from tension-type headaches.
- Participant has 15 or more headache days per month reported via migraine eDiary and during screening.
- Participant using any opioid medication at the time of screening.
- Participant has received Botox treatment, barbiturates, supraorbital or occipital nerve blocks within the last 4 weeks of screening.
- Participant lives at an altitude of 2000 meters or more above sea level.
- Self-reported intolerance to intranasal therapy.
- Self-reported recurrent epistaxis or chronic rhinosinusitis.
- Self-reported sinus or intranasal surgery within the last 4 months of screening.
- Self-reported history of 'complicated migraine or headaches' (i.e., hemiplegic migraine, ophthalmoplegic migraine, migrainous infarction, basilar migraine, post-traumatic headaches, post-concussion syndrome).
- Known or suspected pregnancy as self-reported by the prospective participant at the time of screening.
- Prospective participant unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity.
- Self-reported diagnosis of alcohol or substance abuse disorder at the time of screening.
- 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.
- 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.
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CoolTech LLClead
- ObvioHealthcollaborator
Study Sites (1)
ObvioHealth
New York, New York, 10001, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Parth Shah, MD
ObvioHealth
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Blinding for this study will be applied to the Principal Investigator (PI) and the study team. The team members who are directly involved in the analysis of the study results, including the biostatistician, will also be blinded. Only the designated group of team members directly involved in overseeing the logistical and distribution aspects of the study products will be unblinded. As needed, the PI may be unblinded in case of an AE/SAE that may impact participant safety. If the unblinding occurs inadvertently or through PI's need due to an AE/SAE impacting participant safety, that event will be noted as a protocol deviation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2023
First Posted
September 25, 2023
Study Start
November 15, 2023
Primary Completion
June 18, 2024
Study Completion
September 24, 2024
Last Updated
September 26, 2024
Record last verified: 2024-09