Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ObvioHealth | INDUSTRY |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (sham) | Sham Comparator | 2 LPM of ambient air administered intermittently via Mi-Helper for 15 minutes |
|
| Group II (active treatment 1) | Experimental | 4 LPM of dehumidified air administered via Mi-Helper for 15 minutes |
|
| Group III (active treatment 2) | Experimental | 6 LPM of dehumidified air administered via Mi-Helper for 15 minutes |
|
| Group IV (active treatment 3) | Experimental | 10 LPM of dehumidified air administered via Mi-Helper for 15 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0 minutes |
| Pain relief at 24 hours post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Use of rescue medication 2-24 post treatment. | 24 hours | |
| Participants belief of which treatment is received. | 24 hours |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Parth Shah, MD | ObvioHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ObvioHealth | New York | New York | 10001 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42418214 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020325 | Migraine with Aura |
| D020326 | Migraine without Aura |
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
|
|
From severe or moderate to mild or no pain, or from mild to no pain; based on the traditional 4-point VRS scale
| 24 hours |
| Pain freedom immediately post treatment | A reduction of mild, moderate or severe pain at baseline to no pain. | 0 minutes |
| Pain freedom at 2 hours post treatment | A reduction of mild, moderate or severe pain at baseline to no pain. | 2 hours |
| Pain freedom at 24 hours post treatment | A reduction of mild, moderate or severe pain at baseline to no pain. | 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 | 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 | 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 | 24 hours |
| Freedom from MBS immediately post treatment | A reduction of mild, moderate or severe pain at baseline to none. | 0 minutes |
| Freedom from MBS at 2 hours post treatment | A reduction of mild, moderate or severe pain at baseline to none. | 2 hours |
| Freedom from MBS at 24 hours post treatment | A reduction of mild, moderate or severe pain at baseline to none. | 24 hours |
| D009422 | Nervous System Diseases |