Status:
COMPLETED
Nasal Cavity Cooling for the Symptomatic Relief of Migraine Headache - a Pilot Study
Lead Sponsor:
Lund University
Collaborating Sponsors:
BrainCool
Conditions:
Migraine
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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". 10-20 patients ...
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-a...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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)
Key Trial Info
Start Date :
March 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04660864
Start Date
March 3 2021
End Date
December 23 2021
Last Update
January 24 2022
Active Locations (1)
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1
Lund University
Lund, Sweden, 22355