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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (active treatment) | Experimental | 10 liters per minute of dehumidified air administered via Mi-Helper for 15 minutes |
|
| Group II (sham) | Sham Comparator | 2 LPM of ambient air administered intermittently 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 Freedom at 2 Hours Post Treatment | Proportion of participants with a change in headache severity from mild/moderate/severe pain at baseline to no pain at 2 hours after treatment completion (if rescue medication was not used) | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post Treatment | Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none at 2 hours post treatment completion. | 2 hours |
| Sustained Pain Freedom at 24 Hours Post Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Rescue Medication Use | Use of rescue medication before 2 hours post treatment completion. | 2 Hours |
| Pain Freedom Immediately Post Treatment | Proportion of participants with a change in headache severity from mild/moderate/severe pain at baseline to no pain at 2 hours after treatment completion (if rescue medication was not used) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Ailani, MD | MedStar Georgetown Headache Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPRIM Pro | Indian Harbour Beach | Florida | 32937 | United States |
Individual participant data that underlie the results reported in the final article including results in the text, tables, figures, and appendices, will be made available after deidentification.
The data will be made available within 6 months of the study's conclusion and will remain available for at least 3 years.
Researchers who provide a methodologically sound proposal to achieve results in line with the proposed outcomes will be able to obtain IPD.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I (Active Treatment) | 10 liters per minute of dehumidified air administered via Mi-Helper for 15 minutes 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. |
| FG001 | Group II (Sham) | 2 LPM of ambient air administered intermittently via Mi-Helper for 15 minutes 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I (Active Treatment) | 10 liters per minute of dehumidified air administered via Mi-Helper for 15 minutes 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Freedom at 2 Hours Post Treatment | Proportion of participants with a change in headache severity from mild/moderate/severe pain at baseline to no pain at 2 hours after treatment completion (if rescue medication was not used) | Posted | Count of Participants | Participants | 2 hours |
|
Adverse events were collected during the 35 day baseline period and for 48 hours post completion of treatment with the study device.
Participants routinely received questionnaires via the study app at pre-set time intervals asking if they had any changes in health or adverse events. There was also an ad-hoc form available to participants throughout the study period to report any changes in health or adverse events in real time.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group I (Active Treatment) | 10 liters per minute of dehumidified air administered via Mi-Helper for 15 minutes 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steve Schaefer, CEO | Mi-Helper, Inc. | 443-845-9780 | sschaefer@cooltechcorp.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 27, 2025 | Aug 4, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 18, 2025 | Aug 13, 2025 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
Proportion of participants with pain freedom with no administration of rescue medication and with no recurrence of a mild/moderate/severe headache |
| 2-24 Hours |
| Pain Relief at 2 Hours Post Treatment | Proportion of participants with a change in headache severity from severe or moderate pain at baseline to mild or no pain at 2 hours post treatment completion, or from mild pain at baseline to no pain no pain at 2 hours after treatment completion (if rescue medication was not used) | 2 hours |
| Participants' Global Impression of Acute Treatment Effect | Measured by the Patient Global Impression of Change (PGIC), on which participants use a 7-point scale, where 1=very much improved to 7=very much worse. Scores of 1 or 2 will be considered successes. | 24 Hours |
| 0 Hours |
| Pain Relief Immediately Post Treatment | Proportion of participants with a change in headache severity from severe or moderate pain at baseline to mild or no pain at 0 hours post treatment completion, or from mild pain at baseline to no pain no pain at 0 hours after treatment completion (if rescue medication was not used) | 0 minutes |
| Sustained Pain Freedom at 48 Hours Post Treatment | Proportion of participants with pain freedom with no administration of rescue medication and with no recurrence of a mild/moderate/severe headache | 2 - 48 Hours |
| Freedom From Most Bothersome Symptom (MBS) at Immediately Post Treatment | Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none immediately post treatment completion. | 0 minutes |
| Relief From Most Bothersome Symptom (MBS) Immediately Post Treatment | Proportion of participants with a change from severe or moderate symptom severity at baseline to the traditional 4-point Visual Rating Scalemild or none at 0 hours, or from mild symptom severity at baseline to none at 0 hours post treatment completion (based on the traditional 4-point Visual Rating Scale) | 0 hours |
| Freedom From Nausea Immediately Post Treatment | Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none immediately post treatment completion (based on the traditional 4-point Visual Rating Scale) | 0 hours |
| Freedom From Photophobia Immediately Post Treatment | Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none ( immediately post treatment completion. | 0 Hours |
| Freedom From Phonophobia Immediately Post Treatment | Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none immediately post treatment completion. | 0 hours |
| Freedom From Nausea at 2 Hours Post Treatment | A reduction from mild, moderate or severe symptom severity at baseline to none at 2 hours post treatment completion. | 2 Hours |
| Freedom From Photophobia at 2 Hours Post Treatment | Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none at 2 hours post treatment completion. | 2 Hours |
| Freedom From Phonophobia at 2 Hours Post Treatment | Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none at 2 hours post treatment completion. | 2 Hours |
| Subject noncompliance |
|
| Technical issue |
|
| BG001 | Group II (Sham) | 2 LPM of ambient air administered intermittently via Mi-Helper for 15 minutes 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Highest Level of Education | Count of Participants | Participants |
|
| OG001 | Group II (Sham) | 2 LPM of ambient air administered intermittently via Mi-Helper for 15 minutes 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. |
|
|
|
| Secondary | Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post Treatment | Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none at 2 hours post treatment completion. | The Modified Intent-to-Treat (mITT) Population included all participants who used the study intervention and completed a baseline and 2-hour post-dose pain assessment. | Posted | Count of Participants | Participants | 2 hours |
|
|
|
|
| Secondary | Sustained Pain Freedom at 24 Hours Post Treatment | Proportion of participants with pain freedom with no administration of rescue medication and with no recurrence of a mild/moderate/severe headache | The Modified Intent-to-Treat (mITT) Population included all participants who used the study intervention and completed a baseline and 2-hour post-dose pain assessment. | Posted | Count of Participants | Participants | 2-24 Hours |
|
|
|
|
| Secondary | Pain Relief at 2 Hours Post Treatment | Proportion of participants with a change in headache severity from severe or moderate pain at baseline to mild or no pain at 2 hours post treatment completion, or from mild pain at baseline to no pain no pain at 2 hours after treatment completion (if rescue medication was not used) | The Modified Intent-to-Treat (mITT) Population included all participants who used the study intervention and completed a baseline and 2-hour post-dose pain assessment. | Posted | Count of Participants | Participants | 2 hours |
|
|
|
|
| Secondary | Participants' Global Impression of Acute Treatment Effect | Measured by the Patient Global Impression of Change (PGIC), on which participants use a 7-point scale, where 1=very much improved to 7=very much worse. Scores of 1 or 2 will be considered successes. | The Modified Intent-to-Treat (mITT) Population included all participants who used the study intervention and completed a baseline and 2-hour post-dose pain assessment. | Posted | Count of Participants | Participants | 24 Hours |
|
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|
|
| Other Pre-specified | Rescue Medication Use | Use of rescue medication before 2 hours post treatment completion. | The Modified Intent-to-Treat (mITT) Population included all participants who used the study intervention and completed a baseline and 2-hour post-dose pain assessment | Posted | Count of Participants | Participants | 2 Hours |
|
|
|
| Other Pre-specified | Pain Freedom Immediately Post Treatment | Proportion of participants with a change in headache severity from mild/moderate/severe pain at baseline to no pain at 2 hours after treatment completion (if rescue medication was not used) | The Modified Intent-to-Treat (mITT) Population included all participants who used the study intervention and completed a baseline and 2-hour post-dose pain assessment | Posted | Count of Participants | Participants | 0 Hours |
|
|
|
| Other Pre-specified | Pain Relief Immediately Post Treatment | Proportion of participants with a change in headache severity from severe or moderate pain at baseline to mild or no pain at 0 hours post treatment completion, or from mild pain at baseline to no pain no pain at 0 hours after treatment completion (if rescue medication was not used) | The Modified Intent-to-Treat (mITT) Population included all participants who used the study intervention and completed a baseline and 2-hour post-dose pain assessment | Posted | Count of Participants | Participants | 0 minutes |
|
|
|
| Other Pre-specified | Sustained Pain Freedom at 48 Hours Post Treatment | Proportion of participants with pain freedom with no administration of rescue medication and with no recurrence of a mild/moderate/severe headache | The Modified Intent-to-Treat (mITT) Population included all participants who used the study intervention and completed a baseline and 2-hour post-dose pain assessment | Posted | Count of Participants | Participants | 2 - 48 Hours |
|
|
|
| Other Pre-specified | Freedom From Most Bothersome Symptom (MBS) at Immediately Post Treatment | Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none immediately post treatment completion. | The Modified Intent-to-Treat (mITT) Population included all participants who used the study intervention and completed a baseline and 2-hour post-dose pain assessment | Posted | Count of Participants | Participants | 0 minutes |
|
|
|
| Other Pre-specified | Relief From Most Bothersome Symptom (MBS) Immediately Post Treatment | Proportion of participants with a change from severe or moderate symptom severity at baseline to the traditional 4-point Visual Rating Scalemild or none at 0 hours, or from mild symptom severity at baseline to none at 0 hours post treatment completion (based on the traditional 4-point Visual Rating Scale) | The Modified Intent-to-Treat (mITT) Population included all participants who used the study intervention and completed a baseline and 2-hour post-dose pain assessment | Posted | Count of Participants | Participants | 0 hours |
|
|
|
| Other Pre-specified | Freedom From Nausea Immediately Post Treatment | Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none immediately post treatment completion (based on the traditional 4-point Visual Rating Scale) | The Modified Intent-to-Treat (mITT) Population included all participants who used the study intervention and completed a baseline and 2-hour post-dose pain assessment. Only subjects who reported nausea at baseline were included in this analysis. | Posted | Count of Participants | Participants | 0 hours |
|
|
|
| Other Pre-specified | Freedom From Photophobia Immediately Post Treatment | Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none ( immediately post treatment completion. | The Modified Intent-to-Treat (mITT) Population included all participants who used the study intervention and completed a baseline and 2-hour post-dose pain assessment. Only subjects who reported photophobia at baseline were included in this analysis. | Posted | Count of Participants | Participants | 0 Hours |
|
|
|
| Other Pre-specified | Freedom From Phonophobia Immediately Post Treatment | Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none immediately post treatment completion. | The Modified Intent-to-Treat (mITT) Population included all participants who used the study intervention and completed a baseline and 2-hour post-dose pain assessment. Only subjects who reported phonophobia at baseline were included in this analysis. | Posted | Count of Participants | Participants | 0 hours |
|
|
|
| Other Pre-specified | Freedom From Nausea at 2 Hours Post Treatment | A reduction from mild, moderate or severe symptom severity at baseline to none at 2 hours post treatment completion. | The Modified Intent-to-Treat (mITT) Population included all participants who used the study intervention and completed a baseline and 2-hour post-dose pain assessment. Only subjects who reported nausea at baseline were included in this analysis. | Posted | Count of Participants | Participants | 2 Hours |
|
|
|
| Other Pre-specified | Freedom From Photophobia at 2 Hours Post Treatment | Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none at 2 hours post treatment completion. | The Modified Intent-to-Treat (mITT) Population included all participants who used the study intervention and completed a baseline and 2-hour post-dose pain assessment. Only subjects who reported photophobia at baseline were included in this analysis. | Posted | Count of Participants | Participants | 2 Hours |
|
|
|
| Other Pre-specified | Freedom From Phonophobia at 2 Hours Post Treatment | Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none at 2 hours post treatment completion. | The Modified Intent-to-Treat (mITT) Population included all participants who used the study intervention and completed a baseline and 2-hour post-dose pain assessment. Only subjects who reported phonophobia at baseline were included in this analysis. | Posted | Count of Participants | Participants | 2 Hours |
|
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| 0 |
| 77 |
| 0 |
| 77 |
| 8 |
| 77 |
| EG001 | Group II (Sham) | 2 LPM of ambient air administered intermittently via Mi-Helper for 15 minutes 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. | 0 | 79 | 0 | 79 | 3 | 79 |
| Rhinovirus Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Heart Rate Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Pain in Jaw | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nasal Discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |