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Trial Outcomes & Findings for Cooling to Alleviate Migraine #3 (NCT NCT06874361)

NCT ID: NCT06874361

Last Updated: 2026-02-10

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

156 participants

Primary outcome timeframe

2 hours

Results posted on

2026-02-10

Participant Flow

Participant milestones

Participant milestones
Measure
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.
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.
Overall Study
STARTED
77
79
Overall Study
COMPLETED
61
64
Overall Study
NOT COMPLETED
16
15

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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.
Overall Study
Physician Decision
1
0
Overall Study
Did not treat
13
12
Overall Study
Subject noncompliance
1
3
Overall Study
Technical issue
1
0

Baseline Characteristics

Cooling to Alleviate Migraine #3

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Group I (Active Treatment)
n=77 Participants
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.
Group II (Sham)
n=79 Participants
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.
Total
n=156 Participants
Total of all reporting groups
Age, Continuous
39.7 years
STANDARD_DEVIATION 8.6 • n=41 Participants
40.5 years
STANDARD_DEVIATION 9.4 • n=1581 Participants
40.1 years
STANDARD_DEVIATION 9.0 • n=4626 Participants
Sex/Gender, Customized
Male
11 Participants
n=41 Participants
12 Participants
n=1581 Participants
23 Participants
n=4626 Participants
Sex/Gender, Customized
Female
66 Participants
n=41 Participants
66 Participants
n=1581 Participants
132 Participants
n=4626 Participants
Sex/Gender, Customized
Other or Prefer Not to Say
0 Participants
n=41 Participants
1 Participants
n=1581 Participants
1 Participants
n=4626 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants
n=41 Participants
7 Participants
n=1581 Participants
17 Participants
n=4626 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
67 Participants
n=41 Participants
72 Participants
n=1581 Participants
139 Participants
n=4626 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=41 Participants
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=41 Participants
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
Race (NIH/OMB)
Asian
2 Participants
n=41 Participants
2 Participants
n=1581 Participants
4 Participants
n=4626 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=41 Participants
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
Race (NIH/OMB)
Black or African American
6 Participants
n=41 Participants
3 Participants
n=1581 Participants
9 Participants
n=4626 Participants
Race (NIH/OMB)
White
63 Participants
n=41 Participants
71 Participants
n=1581 Participants
134 Participants
n=4626 Participants
Race (NIH/OMB)
More than one race
4 Participants
n=41 Participants
2 Participants
n=1581 Participants
6 Participants
n=4626 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=41 Participants
1 Participants
n=1581 Participants
3 Participants
n=4626 Participants
Region of Enrollment
United States
77 participants
n=41 Participants
79 participants
n=1581 Participants
156 participants
n=4626 Participants
Highest Level of Education
Some high school
0 Participants
n=41 Participants
0 Participants
n=1581 Participants
0 Participants
n=4626 Participants
Highest Level of Education
High school diploma (or GED)
4 Participants
n=41 Participants
3 Participants
n=1581 Participants
7 Participants
n=4626 Participants
Highest Level of Education
Some college
17 Participants
n=41 Participants
13 Participants
n=1581 Participants
30 Participants
n=4626 Participants
Highest Level of Education
Vocational school or Certificate program
1 Participants
n=41 Participants
7 Participants
n=1581 Participants
8 Participants
n=4626 Participants
Highest Level of Education
College or university degree (2- or 4-year)
34 Participants
n=41 Participants
23 Participants
n=1581 Participants
57 Participants
n=4626 Participants
Highest Level of Education
Graduate degree
21 Participants
n=41 Participants
32 Participants
n=1581 Participants
53 Participants
n=4626 Participants
Highest Level of Education
Other
0 Participants
n=41 Participants
1 Participants
n=1581 Participants
1 Participants
n=4626 Participants

PRIMARY outcome

Timeframe: 2 hours

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)

Outcome measures

Outcome measures
Measure
Group I (Active Treatment)
n=61 Participants
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.
Group II (Sham)
n=64 Participants
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.
Pain Freedom at 2 Hours Post Treatment
15 Participants
14 Participants

SECONDARY outcome

Timeframe: 2 hours

Population: 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.

Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none at 2 hours post treatment completion.

Outcome measures

Outcome measures
Measure
Group I (Active Treatment)
n=61 Participants
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.
Group II (Sham)
n=64 Participants
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.
Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post Treatment
21 Participants
26 Participants

SECONDARY outcome

Timeframe: 2-24 Hours

Population: 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.

Proportion of participants with pain freedom with no administration of rescue medication and with no recurrence of a mild/moderate/severe headache

Outcome measures

Outcome measures
Measure
Group I (Active Treatment)
n=61 Participants
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.
Group II (Sham)
n=64 Participants
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.
Sustained Pain Freedom at 24 Hours Post Treatment
8 Participants
11 Participants

SECONDARY outcome

Timeframe: 2 hours

Population: 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.

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)

Outcome measures

Outcome measures
Measure
Group I (Active Treatment)
n=61 Participants
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.
Group II (Sham)
n=64 Participants
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.
Pain Relief at 2 Hours Post Treatment
35 Participants
38 Participants

SECONDARY outcome

Timeframe: 24 Hours

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Group I (Active Treatment)
n=61 Participants
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.
Group II (Sham)
n=64 Participants
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.
Participants' Global Impression of Acute Treatment Effect
Successful Improvement
20 Participants
32 Participants
Participants' Global Impression of Acute Treatment Effect
Unsuccessful Improvement
41 Participants
32 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Hours

Population: 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

Use of rescue medication before 2 hours post treatment completion.

Outcome measures

Outcome measures
Measure
Group I (Active Treatment)
n=61 Participants
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.
Group II (Sham)
n=64 Participants
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.
Rescue Medication Use
5 Participants
3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 Hours

Population: 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

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)

Outcome measures

Outcome measures
Measure
Group I (Active Treatment)
n=61 Participants
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.
Group II (Sham)
n=64 Participants
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.
Pain Freedom Immediately Post Treatment
6 Participants
5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 minutes

Population: 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

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)

Outcome measures

Outcome measures
Measure
Group I (Active Treatment)
n=61 Participants
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.
Group II (Sham)
n=64 Participants
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.
Pain Relief Immediately Post Treatment
28 Participants
26 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 - 48 Hours

Population: 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

Proportion of participants with pain freedom with no administration of rescue medication and with no recurrence of a mild/moderate/severe headache

Outcome measures

Outcome measures
Measure
Group I (Active Treatment)
n=61 Participants
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.
Group II (Sham)
n=64 Participants
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.
Sustained Pain Freedom at 48 Hours Post Treatment
13 Participants
11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 minutes

Population: 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

Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none immediately post treatment completion.

Outcome measures

Outcome measures
Measure
Group I (Active Treatment)
n=61 Participants
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.
Group II (Sham)
n=64 Participants
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.
Freedom From Most Bothersome Symptom (MBS) at Immediately Post Treatment
9 Participants
8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 hours

Population: 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

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)

Outcome measures

Outcome measures
Measure
Group I (Active Treatment)
n=61 Participants
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.
Group II (Sham)
n=64 Participants
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.
Relief From Most Bothersome Symptom (MBS) Immediately Post Treatment
28 Participants
31 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 hours

Population: 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.

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)

Outcome measures

Outcome measures
Measure
Group I (Active Treatment)
n=39 Participants
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.
Group II (Sham)
n=40 Participants
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.
Freedom From Nausea Immediately Post Treatment
17 Participants
11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 Hours

Population: 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.

Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none ( immediately post treatment completion.

Outcome measures

Outcome measures
Measure
Group I (Active Treatment)
n=51 Participants
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.
Group II (Sham)
n=60 Participants
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.
Freedom From Photophobia Immediately Post Treatment
9 Participants
9 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 hours

Population: 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.

Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none immediately post treatment completion.

Outcome measures

Outcome measures
Measure
Group I (Active Treatment)
n=47 Participants
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.
Group II (Sham)
n=56 Participants
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.
Freedom From Phonophobia Immediately Post Treatment
7 Participants
14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Hours

Population: 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.

A reduction from mild, moderate or severe symptom severity at baseline to none at 2 hours post treatment completion.

Outcome measures

Outcome measures
Measure
Group I (Active Treatment)
n=39 Participants
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.
Group II (Sham)
n=40 Participants
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.
Freedom From Nausea at 2 Hours Post Treatment
24 Participants
18 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Hours

Population: 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.

Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none at 2 hours post treatment completion.

Outcome measures

Outcome measures
Measure
Group I (Active Treatment)
n=52 Participants
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.
Group II (Sham)
n=60 Participants
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.
Freedom From Photophobia at 2 Hours Post Treatment
18 Participants
26 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Hours

Population: 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.

Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none at 2 hours post treatment completion.

Outcome measures

Outcome measures
Measure
Group I (Active Treatment)
n=47 Participants
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.
Group II (Sham)
n=56 Participants
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.
Freedom From Phonophobia at 2 Hours Post Treatment
18 Participants
26 Participants

Adverse Events

Group I (Active Treatment)

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Group II (Sham)

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Group I (Active Treatment)
n=77 participants at risk
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.
Group II (Sham)
n=79 participants at risk
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.
Psychiatric disorders
Depression
1.3%
1/77 • Number of events 1 • 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.
0.00%
0/79 • 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.
Respiratory, thoracic and mediastinal disorders
Epistaxis
1.3%
1/77 • Number of events 1 • 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.
0.00%
0/79 • 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.
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
1.3%
1/77 • Number of events 1 • 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.
1.3%
1/79 • Number of events 1 • 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.
Skin and subcutaneous tissue disorders
Erythema
1.3%
1/77 • Number of events 1 • 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.
0.00%
0/79 • 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.
Infections and infestations
Covid-19
1.3%
1/77 • Number of events 1 • 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.
0.00%
0/79 • 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.
Infections and infestations
Rhinovirus Infection
1.3%
1/77 • Number of events 1 • 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.
0.00%
0/79 • 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.
Investigations
Heart Rate Increased
0.00%
0/77 • 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.
1.3%
1/79 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders
Pain in Jaw
1.3%
1/77 • Number of events 1 • 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.
0.00%
0/79 • 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.
Nervous system disorders
Dysgeusia
0.00%
0/77 • 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.
1.3%
1/79 • Number of events 1 • 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.
Nervous system disorders
Headache
1.3%
1/77 • Number of events 1 • 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.
0.00%
0/79 • 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.

Additional Information

Steve Schaefer, CEO

Mi-Helper, Inc.

Phone: 443-845-9780

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place