TerminatedNCT04936061Updated Sep 29, 2023Results posted

Transnasal Cooling for Migraine

An interventional study of CoolStat active device and CoolStat sham device in Migraine, Episodic Migraine and Migraine With Aura, sponsored by CoolTech LLC. Terminated at 3 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-29.

Sponsored by CoolTech LLC · Not applicable, Interventional, and Treatment

Why this study was terminated

Recruitment problems

Phase: Not applicable
Study type: Interventional
Enrollment: 24
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study summary

This is a prospective, double-blind, sham-controlled, randomized study to assess the safety, tolerability, and optimal dose of the COOLSTAT Transnasal Thermal Regulating Device for acute treatment of migraine. The hypothesis is that evaporative cooling induced by the CoolStat using only ambient, dry air will reduce the pain and other symptoms of migraine headaches during an acute migraine episode.

Conditions studied

Migraine
Episodic Migraine
Migraine With Aura
Migraine Without Aura

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In context

Migraine Disorders

1,558 studies on the registry are indexed under Migraine Disorders; 301 are open to participants now.

This study's enrollment of 24 is below the median of 80 across 1,197 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

CoolTech LLC is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Meets the International Classification of Headache Disorders (ICHD-3) diagnostic criteria for migraine with or without aura, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, ophthalmoplegic migraine, migrainous infarction).
Patient is between 18 and 80 years of age.
Patient experiences 2 to 8 migraine attacks per month.
Patient is in good reported general health, with no fever (\<38.3C/101F).
Patient has had diagnosis of migraine with or without aura over at least 1 year.
Migraine onset before 50 years of age.
Migraine prophylaxis medication unchanged for 6 weeks prior to study enrollment.
Able to attend treatment session within 6 hours of migraine onset, with 48 hours of pain freedom prior to onset of migraine attack.
Migraine pain severity of Grade 2 or Grade 3 on day of treatment.
Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion criteria

Exclusion Criteria:

has difficulty distinguishing his or her migraine attacks from tension-type headaches
Patient has uncontrolled hypertension.
Patient has a fever (≥38.3C / 101F).
Patient has used opioid medication or barbiturates in the past month.
Patient has Medication Overuse Headache (MOH), New Daily Persistent Headache (NDPH) or Chronic Tension Type Headache (CTTH).
Patient has 15 or more headache days per month.
Patient has used acute treatment(s) for migraine in the 48 hours preceding treatment i.e. over-the-counter (OTC) medications, prescription medications, or medical device).
Patient has received Botox treatment, supraorbital or occipital nerve blocks in the last 4 weeks.
Intolerance to intranasal neurostimulation or sensory processing disorder that makes the treatment not applicable.
Recurrent epistaxis or chronic rhinosinusitis.
Recent facial trauma, sinus or intranasal surgery within the last 4 months.
Known or suspected pregnancy.
Unable to fully understand the consent process and provide informed consent due to either language barriers or mental capacity.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 24 participants (actual)

Study arms

Experimental
High flow treatment
15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.
Device: CoolStat active device
Experimental
Low flow treatment
15 minute transnasal air flow therapy with the CoolStat active device as an abortive treatment for migraine attack.
Device: CoolStat active device
Sham comparator
Sham flow ambient air
15 minute transnasal air flow therapy with the CoolStat sham device as an abortive treatment for migraine attack.
Device: CoolStat sham device

Interventions

DeviceCoolStat active device
The CoolStat active device will administer a therapeutic flow of dry air into the nostril.
DeviceCoolStat sham device
The CoolStat sham device will administer a sham flow of ambient air into the nostril.

What researchers measure

Primary outcomes

Pain Relief
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 2 hours after the CoolStat treatment session.
Time frame: 2 hours
Tolerability of the CoolStat Device
Number of subjects who fail to complete the full treatment session
Time frame: 15 minutes
Safety of the CoolStat Device
Number of participants with device-related adverse events
Time frame: 24 hours

Secondary outcomes

Pain Relief
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) immediately after the CoolStat treatment session.
Time frame: 0 minutes
Pain Relief
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 24 hours after the CoolStat treatment session without the use of rescue medication
Time frame: 24 hours
Pain Freedom
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the CoolStat treatment session without the use of rescue medication
Time frame: 2 hours
Pain Freedom
The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 24 hours after the CoolStat treatment session without the use of rescue medication.
Time frame: 24 hours
Relief From Migraine-associated Symptoms
The percentage of patients having a reduction in symptom severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-treatment session without the use of rescue medication.
Time frame: 2 hours
Freedom From Migraine-associated Symptoms
The percentage of patients with absence of photophobia, phonophobia, nausea and vomiting, at 2 hours after the end of the CoolStat treatment session without the use of rescue medication
Time frame: 2 hours
Use of Rescue Medication
The percentage of patients who took acute anti-migraine medication within 24 hours after the end of the CoolStat treatment session.
Time frame: 0 to 24 hours

Results

Posted Sep 29, 2023

Participant flow

Participant flow — Overall Study
Milestone	High Flow Treatment	Low Flow Treatment	Sham Flow Ambient Air
Started	6	9	9
Completed	6	9	9
Not completed	0	0	0

Outcome measures

PrimaryPain Relief

The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 2 hours after the CoolStat treatment session.

Time frame:: 2 hours
Reported as:: Count of participants · Participants

Pain Relief
Participants	High Flow Treatment	Low Flow Treatment	Sham Flow Ambient Air
Pain Relief	3	4	8

PrimaryTolerability of the CoolStat Device

Number of subjects who fail to complete the full treatment session

Time frame:: 15 minutes
Reported as:: Count of participants · Participants

Tolerability of the CoolStat Device
Participants	High Flow Treatment	Low Flow Treatment	Sham Flow Ambient Air
Tolerability of the CoolStat Device	2	1	0

PrimarySafety of the CoolStat Device

Number of participants with device-related adverse events

Time frame:: 24 hours
Reported as:: Count of participants · Participants

Safety of the CoolStat Device
Participants	High Flow Treatment	Low Flow Treatment	Sham Flow Ambient Air
Safety of the CoolStat Device	3	3	0

SecondaryPain Relief

The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) immediately after the CoolStat treatment session.

Time frame:: 0 minutes
Reported as:: Count of participants · Participants

Pain Relief
Participants	High Flow Treatment	Low Flow Treatment	Sham Flow Ambient Air
Pain Relief	0	3	7

SecondaryPain Relief

The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 24 hours after the CoolStat treatment session without the use of rescue medication

Time frame:: 24 hours
Reported as:: Count of participants · Participants

Pain Relief
Participants	High Flow Treatment	Low Flow Treatment	Sham Flow Ambient Air
Pain Relief	1	2	5

SecondaryPain Freedom

The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the CoolStat treatment session without the use of rescue medication

Time frame:: 2 hours
Reported as:: Count of participants · Participants

Pain Freedom
Participants	High Flow Treatment	Low Flow Treatment	Sham Flow Ambient Air
Pain Freedom	0	0	4

SecondaryPain Freedom

The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 24 hours after the CoolStat treatment session without the use of rescue medication.

Time frame:: 24 hours
Reported as:: Count of participants · Participants

Pain Freedom
Participants	High Flow Treatment	Low Flow Treatment	Sham Flow Ambient Air
Pain Freedom	1	0	4

SecondaryRelief From Migraine-associated Symptoms

The percentage of patients having a reduction in symptom severity from Grade 3/2 at baseline to Grade 1/0 at 2 hours post-treatment session without the use of rescue medication.

Time frame:: 2 hours
Reported as:: Count of participants · Participants

Relief From Migraine-associated Symptoms
Participants	High Flow Treatment	Low Flow Treatment	Sham Flow Ambient Air
Relief From Migraine-associated Symptoms	4	6	7

SecondaryFreedom From Migraine-associated Symptoms

The percentage of patients with absence of photophobia, phonophobia, nausea and vomiting, at 2 hours after the end of the CoolStat treatment session without the use of rescue medication

Time frame:: 2 hours
Reported as:: Count of participants · Participants

Freedom From Migraine-associated Symptoms
Participants	High Flow Treatment	Low Flow Treatment	Sham Flow Ambient Air
Freedom From Migraine-associated Symptoms	3	3	5

SecondaryUse of Rescue Medication

The percentage of patients who took acute anti-migraine medication within 24 hours after the end of the CoolStat treatment session.

Time frame:: 0 to 24 hours
Reported as:: Count of participants · Participants

Use of Rescue Medication
Participants	High Flow Treatment	Low Flow Treatment	Sham Flow Ambient Air
Use of Rescue Medication	4	8	4

Adverse events

Collected over 24 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
High Flow Treatment	0/6 (0%)	0/6 (0%)	3/6 (50%)
Low Flow Treatment	0/9 (0%)	0/9 (0%)	3/9 (33.3%)
Sham Flow Ambient Air	0/9 (0%)	0/9 (0%)	0/9 (0%)

Most frequent other events

Most frequent other events
Event	High Flow Treatment	Low Flow Treatment	Sham Flow Ambient Air
Burning sensation in nostrilSkin and subcutaneous tissue disorders	2/6	1/9	0/9
Increased head painNervous system disorders	1/6	1/9	0/9
DizzinessNervous system disorders	1/6	0/9	0/9
Nasal congestionGeneral disorders	0/6	1/9	0/9

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	High Flow Treatment	Low Flow Treatment	Sham Flow Ambient Air	Total
<=18 years	0	0	0	0
Between 18 and 65 years	6	8	8	22
>=65 years	0	1	1	2

Age, Continuous
Age, Continuous(years)	High Flow Treatment	Low Flow Treatment	Sham Flow Ambient Air	Total
Mean	37.8 ± 12.3	51.4 ± 13.2	50.3 ± 9.7	47.6 ± 12.6

Sex: Female, Male
Sex: Female, Male(Participants)	High Flow Treatment	Low Flow Treatment	Sham Flow Ambient Air	Total
Female	6	9	9	24
Male	0	0	0	0

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	High Flow Treatment	Low Flow Treatment	Sham Flow Ambient Air	Total
Hispanic or Latino	0	0	1	1
Not Hispanic or Latino	6	9	8	23
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	High Flow Treatment	Low Flow Treatment	Sham Flow Ambient Air	Total
American Indian or Alaska Native	0	0	0	0
Asian	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	1	1	1	3
White	5	8	7	20
More than one race	0	0	0	0
Unknown or Not Reported	0	0	1	1

Region of Enrollment
Region of Enrollment(Participants)	High Flow Treatment	Low Flow Treatment	Sham Flow Ambient Air	Total
United States	6	9	9	24

Study locations

3 sites

Mayo Clinic
Scottsdale, Arizona 85259, United States
Michigan State University
East Lansing, Michigan 48824, United States
Atrium Health Neurosciences Institute
Charlotte, North Carolina 28207, United States

References and documents

Study documents

Protocol and statistical analysis plan · Jul 2, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04936061
Lead sponsor: CoolTech LLC
Responsible party: Sponsor
First posted: Jun 23, 2021
Start date: Oct 14, 2021
Primary completion: Aug 31, 2022
Completion: Sep 30, 2022
Results posted: Sep 29, 2023
Last update: Sep 29, 2023

Study contacts

Nauman Tariq, MD

principal investigator · Atrium Health Neurosciences Institute

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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