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Mi-Helper Transnasal Cooling for Acute Treatment of Migraine

Primary Purpose

Episodic Migraine, Migraine With Aura, Migraine Without Aura

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mi-Helper
Sponsored by
CoolTech LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Episodic Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. Prospective participant has participated in a migraine study or any interventional clinical study within the 6 months prior to screening.

Sites / Locations

  • ObvioHealth

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

Group I (active treatment 1)

Group II (active treatment 2)

Group III (active treatment 3)

Group IV (sham treatment)

Arm Description

4 LPM of dehumidified air administered via Mi-Helper for 15 minutes

6 LPM of dehumidified air administered via Mi-Helper for 15 minutes

10 LPM of dehumidified air administered via Mi-Helper for 15 minutes

2 LPM of ambient air administered intermittently via Mi-Helper for 15 minutes

Outcomes

Primary Outcome Measures

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
Safety of the Mi-Helper device
Measured by incidence of adverse events
Tolerability of the Mi-Helper device
Based on percent of participants who fail to complete the full treatment session

Secondary Outcome Measures

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
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
Pain freedom immediately post treatment
A reduction of mild, moderate or severe pain at baseline to no pain.
Pain freedom at 2 hours post treatment
A reduction of mild, moderate or severe pain at baseline to no pain.
Pain freedom at 24 hours post treatment
A reduction of mild, moderate or severe pain at baseline to no pain.
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
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
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
Freedom from MBS immediately post treatment
A reduction of mild, moderate or severe pain at baseline to none.
Freedom from MBS at 2 hours post treatment
A reduction of mild, moderate or severe pain at baseline to none.
Freedom from MBS at 24 hours post treatment
A reduction of mild, moderate or severe pain at baseline to none.

Full Information

First Posted
September 18, 2023
Last Updated
October 10, 2023
Sponsor
CoolTech LLC
Collaborators
ObvioHealth
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1. Study Identification

Unique Protocol Identification Number
NCT06051604
Brief Title
Mi-Helper Transnasal Cooling for Acute Treatment of Migraine
Official Title
A Prospective, Double-blind, Sham-controlled, Randomized Two-part Adaptive 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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CoolTech LLC
Collaborators
ObvioHealth

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, double-blind, sham-controlled, randomized two-part clinical trial with an adaptive design. 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. This study will be conducted in two parts. The first part of this study aims to determine the most effective dose of Mi-Helper and the second part aims to evaluate the efficacy, safety, and tolerability of the most effective dose of the Mi-Helper device for the acute treatment of episodic migraine in adults. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Episodic Migraine, Migraine With Aura, Migraine Without Aura, Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (active treatment 1)
Arm Type
Experimental
Arm Description
4 LPM of dehumidified air administered via Mi-Helper for 15 minutes
Arm Title
Group II (active treatment 2)
Arm Type
Experimental
Arm Description
6 LPM of dehumidified air administered via Mi-Helper for 15 minutes
Arm Title
Group III (active treatment 3)
Arm Type
Experimental
Arm Description
10 LPM of dehumidified air administered via Mi-Helper for 15 minutes
Arm Title
Group IV (sham treatment)
Arm Type
Sham Comparator
Arm Description
2 LPM of ambient air administered intermittently via Mi-Helper for 15 minutes
Intervention Type
Device
Intervention Name(s)
Mi-Helper
Other Intervention Name(s)
Mi-Helper transnasal cooling device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain relief at 2 hours post treatment
Description
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
Title
Safety of the Mi-Helper device
Description
Measured by incidence of adverse events
Time Frame
24 hours
Title
Tolerability of the Mi-Helper device
Description
Based on percent of participants who fail to complete the full treatment session
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Pain relief immediately post treatment
Description
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
Title
Pain relief at 24 hours post treatment
Description
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
Title
Pain freedom immediately post treatment
Description
A reduction of mild, moderate or severe pain at baseline to no pain.
Time Frame
0 minutes
Title
Pain freedom at 2 hours post treatment
Description
A reduction of mild, moderate or severe pain at baseline to no pain.
Time Frame
2 hours
Title
Pain freedom at 24 hours post treatment
Description
A reduction of mild, moderate or severe pain at baseline to no pain.
Time Frame
24 hours
Title
Relief from most bothersome symptom (MBS) immediately post treatment
Description
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
Title
Relief from MBS at 2 hours post treatment
Description
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
Title
Relief from MBS at 24 hours post treatment
Description
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
Title
Freedom from MBS immediately post treatment
Description
A reduction of mild, moderate or severe pain at baseline to none.
Time Frame
0 minutes
Title
Freedom from MBS at 2 hours post treatment
Description
A reduction of mild, moderate or severe pain at baseline to none.
Time Frame
2 hours
Title
Freedom from MBS at 24 hours post treatment
Description
A reduction of mild, moderate or severe pain at baseline to none.
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
Use of rescue medication 2-24 post treatment.
Time Frame
24 hours
Title
Participants belief of which treatment is received.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Prospective participant has participated in a migraine study or any interventional clinical study within the 6 months prior to screening.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joy Holland
Phone
5702288140
Email
jholland@cooltechcorp.com
First Name & Middle Initial & Last Name or Official Title & Degree
Casey Hannan
Email
channan@cooltechcorp.co
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parth Shah, MD
Organizational Affiliation
ObvioHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
ObvioHealth
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prakash Limbachiya
Email
prakash.limbachiya@obviohealth.com
First Name & Middle Initial & Last Name & Degree
Parth Shah, MD

12. IPD Sharing Statement

Learn more about this trial

Mi-Helper Transnasal Cooling for Acute Treatment of Migraine

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