Episodic MigraineNCT06051604
Mi-Helper Transnasal Cooling for Acute Treatment of Migraine
A study testing Mi-Helper in people with Episodic Migraine and Migraine With Aura, run by CoolTech LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Episodic Migraine, Migraine With Aura, Migraine Without Aura
- What is being tested?
- Mi-Helper
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2023to 24 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Prospective participant has participated in a migraine study or any interventional clinical study within the 6 months prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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
- Being tested
- Mi-Helper
- Medical subject headings
- Migraine with Aura, Migraine without Aura, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mi-HelperDevice
Also called Mi-Helper transnasal cooling 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 group | Role | What they receive |
|---|---|---|
| Group I (sham) | Sham comparator | 2 LPM of ambient air administered intermittently via Mi-Helper for 15 minutes Receives: Device: Mi-Helper |
| Group II (active treatment 1) | Experimental | 4 LPM of dehumidified air administered via Mi-Helper for 15 minutes Receives: Device: Mi-Helper |
| Group III (active treatment 2) | Experimental | 6 LPM of dehumidified air administered via Mi-Helper for 15 minutes Receives: Device: Mi-Helper |
| Group IV (active treatment 3) | Experimental | 10 LPM of dehumidified air administered via Mi-Helper for 15 minutes Receives: Device: Mi-Helper |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 hours
Safety of the Mi-Helper device
Measured by incidence of adverse events
Measured: 24 hours
Tolerability of the Mi-Helper device
Based on percent of participants who fail to complete the full treatment session
Measured: 15 minutes
Secondary outcomes (11)
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
Measured: 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
Measured: 24 hours
Pain freedom immediately post treatment
A reduction of mild, moderate or severe pain at baseline to no pain.
Measured: 0 minutes
Pain freedom at 2 hours post treatment
A reduction of mild, moderate or severe pain at baseline to no pain.
Measured: 2 hours
Pain freedom at 24 hours post treatment
A reduction of mild, moderate or severe pain at baseline to no pain.
Measured: 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
Measured: 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
Measured: 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
Measured: 24 hours
Freedom from MBS immediately post treatment
A reduction of mild, moderate or severe pain at baseline to none.
Measured: 0 minutes
Freedom from MBS at 2 hours post treatment
A reduction of mild, moderate or severe pain at baseline to none.
Measured: 2 hours
Freedom from MBS at 24 hours post treatment
A reduction of mild, moderate or severe pain at baseline to none.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start15 Nov 2023
- Primary completion18 Jun 2024
- Study completion24 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Episodic MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- CoolTech LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ObvioHealth
- Responsible party
- Sponsor
- Investigators
- Parth Shah, MD, Principal investigator, ObvioHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051604
- Sponsor's protocol ID
- COT-001
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2023
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Mays M, Fanning KM, Tepper SJ. Safety and tolerability of transnasal evaporative cooling for the acute treatment of migraine in an at-home setting: A randomized, double-blind, sham-controlled, decentralized clinical trial. Headache. 2026 Jul 8. doi: 10.1111/head.70184. Online ahead of print.
PubMed 42418214
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06051604
- Acronym / sponsor ID
- COT-001
- Conditions
- Episodic Migraine, Migraine With Aura, Migraine Without Aura, Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- CoolTech LLCIndustry (pharma, biotech, devices)
- Collaborators
- ObvioHealth
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I (sham) | Sham comparator | Device: Mi-Helper2 LPM of ambient air administered intermittently via Mi-Helper for 15 minutes |
| Group II (active treatment 1) | Experimental | Device: Mi-Helper4 LPM of dehumidified air administered via Mi-Helper for 15 minutes |
| Group III (active treatment 2) | Experimental | Device: Mi-Helper6 LPM of dehumidified air administered via Mi-Helper for 15 minutes |
| Group IV (active treatment 3) | Experimental | Device: Mi-Helper10 LPM of dehumidified air administered via Mi-Helper for 15 minutes |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mi-HelperAlso: Mi-Helper transnasal cooling deviceThe 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. | Device | Group I (sham), Group II (active treatment 1), Group III (active treatment 2), Group IV (active treatment 3) |
Primary outcome
Pain relief at 2 hours post treatment
Time frame: 2 hours
From severe or moderate to mild or no pain, or from mild to no pain; based on the traditional 4-point VRS scale
Safety of the Mi-Helper device
Time frame: 24 hours
Measured by incidence of adverse events
Tolerability of the Mi-Helper device
Time frame: 15 minutes
Based on percent of participants who fail to complete the full treatment session
11 secondary outcomes
Pain relief immediately post treatment
Time frame: 0 minutes
Pain relief at 24 hours post treatment
Time frame: 24 hours
Pain freedom immediately post treatment
Time frame: 0 minutes
Pain freedom at 2 hours post treatment
Time frame: 2 hours
Pain freedom at 24 hours post treatment
Time frame: 24 hours
Relief from most bothersome symptom (MBS) immediately post treatment
Time frame: 0 minutes
Relief from MBS at 2 hours post treatment
Time frame: 2 hours
Relief from MBS at 24 hours post treatment
Time frame: 24 hours
Freedom from MBS immediately post treatment
Time frame: 0 minutes
Freedom from MBS at 2 hours post treatment
Time frame: 2 hours
Freedom from MBS at 24 hours post treatment
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Derived from this study: PubMed 42418214Mays M, Fanning KM, Tepper SJ. Safety and tolerability of transnasal evaporative cooling for the acute treatment of migraine in an at-home setting: A randomized, double-blind, sham-controlled, decentralized clinical trial. Headache. 2026 Jul 8. doi: 10.1111/head.70184. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parth Shah, MD principal investigator
ObvioHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mi-Helper in people with Episodic Migraine and Migraine With Aura, run by CoolTech LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief at 2 hours post treatment (time frame: 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06051604, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.