MigraineNCT04660864
Nasal Cavity Cooling for the Symptomatic Relief of Migraine Headache - a Pilot Study
A study testing Nasal cavity cooling device. in people with Migraine, run by Lund University at 1 site in Sweden.
Trial summary
The aim of the study is to evaluate the effect of self-administered intranasal cooling for the symptomatic relief of migraine headache and associated symptoms in an "at home setting". Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Nasal cavity cooling device.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 3 Mar 2021to 23 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meets the International Classification of Headache Disorders (2nd edition) criteria for episodic migraine, with or without aura.
- Migraine diagnosis >1 year
- Migraine attacks 2-8 times/month
- Living in Malmö-Lund area
- Reliable contraception (fertile women)
Who cannot join
- Any change of migraine prophylaxis within three months prior to study begin
- Failure of participant to adhere to protocol requirements
- Smoker or smoker in participants household
- Prior nose surgery or intranasal obstruction
- Pregnancy, breast feeding or planned pregnancy during trial period
- Oxygen dependency
- Medical history of skull base fracture or severe facial trauma
- No migraine attacks during prolonged screening phase (60 days)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to evaluate the effect of self-administered intranasal cooling for the symptomatic relief of migraine headache and associated symptoms in an "at home setting".
10-20 patients - who have been diagnosed according to the International Classification of Headache disorders (2nd Edition) criteria for Episodic migraine, with or without aura - will be included in the study.
During a screening period of one month participants will record their migraine symptoms, any treatment and treatment effects. After a minimum om two migraine attacks the participants receive individual instructions on how to use the The RhinoChill® system. During the following treatment period of the study, participants are instructed to treat their upcoming three migraine attacks with 10 minutes of nasal cavity cooling according to the instructions and thereby register symptoms and treatment effects after 10 minutes, 1 hour, 2 hours, 24 hours and 48 hours.
Read the detailed description
Mechanical techniques to alleviate migraine symptoms have been used for many years, cooling and compression being the most frequently applied. Cryotherapy is the most common non-pharmacological self-administered pain-relieving method currently used by migraine sufferers.
The RhinoChill® System is a CE-Marked device that is currently commercially available in Europe. The RhinoChill® device is intended for temperature reduction in patients via the nasal cavity and can be used across a range of medical and surgical indications where reduction in patient temperature is required. The RhinoChill® system was originally designed specifically for use in the pre-hospital, in-hospital, in-clinic or other clinical settings for the induction of therapeutic hypothermia (reduction in brain and body temperature to between 32-34oC), in which other commercial cooling systems are not practical for use. The RhinoChill® system is portable and runs on batteries. The system cools by spraying an evaporative coolant into the nasal cavity via intranasal catheters. A previous study has shown that the use of RhinoChill® intranasal cooling within a clinic environment provided a statistically significant reduction of pain and associated symptoms of migraine at 5 and 10 minutes (during treatment) and at 1 and 2 hours following treatment along with significant effect on pain and symptoms at 24 hours (all p values <0.001).
The aim of the study is to evaluate the effect of intranasal cooling for the symptomatic relief of migraine headache and associated symptoms when the treatment is self-administered by the patient at home.
The proposed study will be single group assignment with treatment self-administered by patients in their own home, with support and oversight from research support staff working under the direction of the investigators.
The study process is as summarized:
Participants will be identified through adverts at Lund University and are able to register interest via telephone or email. They are then contacted by a researcher by telephone for a brief eligibility check and to book a first meeting at the Braincool office.
Meeting 1, at Braincool office (researcher and research support team):
- Eligibility check - stage one (Case Report Form 1)
- Trial information, viewing of device and catheter
- Informed Consent Form complete
- Instruction on how to register migraine attack symptoms and treatment effects in application/CRF2.
Screening period starts. When the participant has registered two migraine attacks during the screeing period the next meeting is booked:
Meeting 2, home visit (research support team):
- Training on how to use the RhinoChill® device safely and how to register migraine symptoms and treatment effects in application/CRF 3
During the following treatment period of the study, participants are instructed to treat their upcoming three migraine attacks with 10 minutes of nasal cavity cooling according to the instructions and thereby register symptoms and treatment effects after 10 minutes, 1 hour, 2 hours, 24 hours and 48 hours.
When the participant has used the RhinoChill® device to treat three episodes of migraine, or a duration of 3 months post-study has passed, the final meeting is booked.
Meeting 3, home visit (research support team):
- Collection of device and other equipment
- Evaluation on any side effects/adverse events/CRF 4.
- Conditions
- Migraine
- Being tested
- Nasal cavity cooling device.
- Keywords
- Migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal cavity cooling device.Device
The RhinoChill® system cools by intranasal evaporation of a liquid coolant sprayed onto the surface of the nasal cavity. The RhinoChill® system is intended for use for the relief of pain and symptoms associated with acute migraine attack.
| Study group | Role | What they receive |
|---|---|---|
| Rhinochill | Experimental | Treatment with nasal cavity cooling 10 minutes during three consecutive migraine attacks. Receives: Device: Nasal cavity cooling device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of headache
Scoring of headache on a 4-graded scale (none-mild-moderate-severe).
Measured: 10 minutes after baseline (immediately after treatment) compared to baseline
Reduction of nausea
Scoring of symptoms on a 4-graded scale (none-mild-moderate-severe) regarding nausea
Measured: 10 minutes after baseline (immediately after treatment) compared to baseline
Reduction of photophobia
Scoring of symptoms on a 4-graded scale (none-mild-moderate-severe) regarding photophobia
Measured: 10 minutes after baseline (immediately after treatment) compared to baseline
Reduction of phonophobia
Scoring of symptoms on a 4-graded scale (none-mild-moderate-severe) regarding photophonia
Measured: 10 minutes after baseline (immediately after treatment) compared to baseline
Secondary outcomes (11)
Headache response
The patient scores the headache symptoms on a 4-graded scale (none-mild-moderate-severe). Any improvement of pain is recorded.
Measured: Comparing baseline/before treatment and 1. immediately following treatment (10 minutes),2. 1 hour, 3. 2 hours and 4. 24 hours following treatment.
Relapse incidence
Frequency of headache returns
Measured: Between 2-48 hours after intervention
Sustained pain freedom, number of patients that sustain pain freedom 2-48 hours after intervention.
pain free with no use of rescue medication or relapse
Measured: 2-48 hours after intervention
Impact on nausea
Scoring of symptoms none-mild-moderate-severe regarding nausea
Measured: At baseline and 1, 2, 24 hours after treatment
Impact on photophobia
Scoring of symptoms none-mild-moderate-severe regarding photophobia
Measured: At baseline and 1, 2, 24 hours after treatment
Impact on phonophobia
Scoring of symptoms none-mild-moderate-severe regarding , photophobia and phonophobia
Measured: At baseline and 1, 2, 24 hours after treatment
Comparison of headache response between RhinoChill compared to standard treatment during screening period
Comparison of average treatment effect on headache respons between standard treatment and intervention. Scoring of headache on a 10-graded scale, where higher values represents more pain
Measured: Screening phase compared to intervention phase
Average headache pain relief
Scoring of pain on a 4-graded scale, (none-mild-moderate-severe) compared to baseline.
Measured: At baseline and 10 minutes, 1, 2 and 24 hours after treatment.
Tolerance to rhinochill cooling - pain
Visual/analogue pain on a 10-graded scale, where higher values represents more pain.
Measured: 10 minutes-1 hour
Tolerance to rhinochill cooling - discomfort
Visual/analogue discomfort score, on a 10-graded scale, where higher values represents more discomfort.
Measured: 10 minutes-1 hour
Adverse events
Any adverse events noted during the treatment, following treatment or during follow up
Measured: through study completion, an approximated average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start3 Mar 2021
- Primary completion23 Dec 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- BrainCool
- Responsible party
- Sponsor
- Investigators
- Patrik Midlöv, Professor, Study chair, Department of Clinical Sciences, Malmö, Lund University, SwedenMoa Wolff, PhD, Principal investigator, Department of Clinical Sciences, Malmö, Lund University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660864
- Sponsor's protocol ID
- 2019-05471
- Other IDs
- 2019
- Status last verified
- Jan 2022
- First submitted
- 17 Nov 2020
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vanderpol J, Bishop B, Matharu M, Glencorse M. Therapeutic effect of intranasal evaporative cooling in patients with migraine: a pilot study. J Headache Pain. 2015 Jan 26;16:5. doi: 10.1186/1129-2377-16-5.
PubMed 25623151Ucler S, Coskun O, Inan LE, Kanatli Y. Cold Therapy in Migraine Patients: Open-label, Non-controlled, Pilot Study. Evid Based Complement Alternat Med. 2006 Dec;3(4):489-93. doi: 10.1093/ecam/nel035. Epub 2006 Jun 15.
PubMed 17173113
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Cavity Cooling for the Symptomatic Relief of Migraine Headache - a Pilot Study
- ClinicalTrials.gov ID
- NCT04660864
- Acronym / sponsor ID
- 2019-05471
- Conditions
- Migraine
- Keywords
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- BrainCool
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate the effect of self-administered intranasal cooling for the symptomatic relief of migraine headache and associated symptoms in an "at home setting".
10-20 patients - who have been diagnosed according to the International Classification of Headache disorders (2nd Edition) criteria for Episodic migraine, with or without aura - will be included in the study.
During a screening period of one month participants will record their migraine symptoms, any treatment and treatment effects. After a minimum om two migraine attacks the participants receive individual instructions on how to use the The RhinoChill® system. During the following treatment period of the study, participants are instructed to treat their upcoming three migraine attacks with 10 minutes of nasal cavity cooling according to the instructions and thereby register symptoms and treatment effects after 10 minutes, 1 hour, 2 hours, 24 hours and 48 hours.
Detailed description
Mechanical techniques to alleviate migraine symptoms have been used for many years, cooling and compression being the most frequently applied. Cryotherapy is the most common non-pharmacological self-administered pain-relieving method currently used by migraine sufferers.
The RhinoChill® System is a CE-Marked device that is currently commercially available in Europe. The RhinoChill® device is intended for temperature reduction in patients via the nasal cavity and can be used across a range of medical and surgical indications where reduction in patient temperature is required. The RhinoChill® system was originally designed specifically for use in the pre-hospital, in-hospital, in-clinic or other clinical settings for the induction of therapeutic hypothermia (reduction in brain and body temperature to between 32-34oC), in which other commercial cooling systems are not practical for use. The RhinoChill® system is portable and runs on batteries. The system cools by spraying an evaporative coolant into the nasal cavity via intranasal catheters. A previous study has shown that the use of RhinoChill® intranasal cooling within a clinic environment provided a statistically significant reduction of pain and associated symptoms of migraine at 5 and 10 minutes (during treatment) and at 1 and 2 hours following treatment along with significant effect on pain and symptoms at 24 hours (all p values <0.001).
The aim of the study is to evaluate the effect of intranasal cooling for the symptomatic relief of migraine headache and associated symptoms when the treatment is self-administered by the patient at home.
The proposed study will be single group assignment with treatment self-administered by patients in their own home, with support and oversight from research support staff working under the direction of the investigators.
The study process is as summarized:
Participants will be identified through adverts at Lund University and are able to register interest via telephone or email. They are then contacted by a researcher by telephone for a brief eligibility check and to book a first meeting at the Braincool office.
Meeting 1, at Braincool office (researcher and research support team):
- Eligibility check - stage one (Case Report Form 1)
- Trial information, viewing of device and catheter
- Informed Consent Form complete
- Instruction on how to register migraine attack symptoms and treatment effects in application/CRF2.
Screening period starts. When the participant has registered two migraine attacks during the screeing period the next meeting is booked:
Meeting 2, home visit (research support team):
- Training on how to use the RhinoChill® device safely and how to register migraine symptoms and treatment effects in application/CRF 3
During the following treatment period of the study, participants are instructed to treat their upcoming three migraine attacks with 10 minutes of nasal cavity cooling according to the instructions and thereby register symptoms and treatment effects after 10 minutes, 1 hour, 2 hours, 24 hours and 48 hours.
When the participant has used the RhinoChill® device to treat three episodes of migraine, or a duration of 3 months post-study has passed, the final meeting is booked.
Meeting 3, home visit (research support team):
- Collection of device and other equipment
- Evaluation on any side effects/adverse events/CRF 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment.
| Arm | Type | Receives |
|---|---|---|
| Rhinochill | Experimental | Device: Nasal cavity cooling device.Treatment with nasal cavity cooling 10 minutes during three consecutive migraine attacks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meets the International Classification of Headache Disorders (2nd edition) criteria for episodic migraine, with or without aura.
- Migraine diagnosis >1 year
- Migraine attacks 2-8 times/month
- Living in Malmö-Lund area
- Reliable contraception (fertile women)
Key exclusion criteria (8 listed)
- Any change of migraine prophylaxis within three months prior to study begin
- Failure of participant to adhere to protocol requirements
- Smoker or smoker in participants household
- Prior nose surgery or intranasal obstruction
- Pregnancy, breast feeding or planned pregnancy during trial period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal cavity cooling device.The RhinoChill® system cools by intranasal evaporation of a liquid coolant sprayed onto the surface of the nasal cavity. The RhinoChill® system is intended for use for the relief of pain and symptoms associated with acute migraine attack. | Device | Rhinochill |
Primary outcome
Reduction of headache
Time frame: 10 minutes after baseline (immediately after treatment) compared to baseline
Scoring of headache on a 4-graded scale (none-mild-moderate-severe).
Reduction of nausea
Time frame: 10 minutes after baseline (immediately after treatment) compared to baseline
Scoring of symptoms on a 4-graded scale (none-mild-moderate-severe) regarding nausea
Reduction of photophobia
Time frame: 10 minutes after baseline (immediately after treatment) compared to baseline
Scoring of symptoms on a 4-graded scale (none-mild-moderate-severe) regarding photophobia
Reduction of phonophobia
Time frame: 10 minutes after baseline (immediately after treatment) compared to baseline
Scoring of symptoms on a 4-graded scale (none-mild-moderate-severe) regarding photophonia
11 secondary outcomes
Headache response
Time frame: Comparing baseline/before treatment and 1. immediately following treatment (10 minutes),2. 1 hour, 3. 2 hours and 4. 24 hours following treatment.
Relapse incidence
Time frame: Between 2-48 hours after intervention
Sustained pain freedom, number of patients that sustain pain freedom 2-48 hours after intervention.
Time frame: 2-48 hours after intervention
Impact on nausea
Time frame: At baseline and 1, 2, 24 hours after treatment
Impact on photophobia
Time frame: At baseline and 1, 2, 24 hours after treatment
Impact on phonophobia
Time frame: At baseline and 1, 2, 24 hours after treatment
Comparison of headache response between RhinoChill compared to standard treatment during screening period
Time frame: Screening phase compared to intervention phase
Average headache pain relief
Time frame: At baseline and 10 minutes, 1, 2 and 24 hours after treatment.
Tolerance to rhinochill cooling - pain
Time frame: 10 minutes-1 hour
Tolerance to rhinochill cooling - discomfort
Time frame: 10 minutes-1 hour
Adverse events
Time frame: through study completion, an approximated average of 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Background: PubMed 25623151Vanderpol J, Bishop B, Matharu M, Glencorse M. Therapeutic effect of intranasal evaporative cooling in patients with migraine: a pilot study. J Headache Pain. 2015 Jan 26;16:5. doi: 10.1186/1129-2377-16-5.
- Background: PubMed 17173113Ucler S, Coskun O, Inan LE, Kanatli Y. Cold Therapy in Migraine Patients: Open-label, Non-controlled, Pilot Study. Evid Based Complement Alternat Med. 2006 Dec;3(4):489-93. doi: 10.1093/ecam/nel035. Epub 2006 Jun 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrik Midlöv, Professor study chair
Department of Clinical Sciences, Malmö, Lund University, Sweden
Moa Wolff, PhD principal investigator
Department of Clinical Sciences, Malmö, Lund University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal cavity cooling device. in people with Migraine, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of headache (time frame: 10 minutes after baseline (immediately after treatment) compared to baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04660864, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.