COOLHEAD 2
Research type
Research Study
Full title
"Intranasal evaporative COOLing for the symptomatic relief of migraine HEADache – A randomized, double blind, placebo controlled study” - The COOLHEAD 2 Study
IRAS ID
167384
Contact name
Jitka Vanderpol
Contact email
Sponsor organisation
Cumbria Partnership NHS Foundation Trust
Duration of Study in the UK
0 years, 6 months, 3 days
Research summary
This study will be a randomised placebo controlled trial examining the effectiveness of using an intranasal evaporative cooling device (the RhinoChill) in providing relief of pain and symptoms of acute migraine. It will involve using two nasal catheters to spray a liquid coolant into the nasal cavity (active device) which provides localised cooling via evaporation, conduction and convection thereby cooling the local nasal tissue and the blood vessels which supply blood to the brain. This cooling effect will cause the blood vessels to constrict as well as stimulating special cold receptors that are thought to be involved in the relief of migraine, thereby providing both pain and associated symptomatic relief. The placebo device will spray compressed air only into the nose with very minimal cooling effect. 60 patients randomised in a 1:1 fashion clustered to three different recruitment sites will be recruited. The patients will have a 30 day period of data collection for their current migraine frequency, treatment and response to medication (with a minimum of 2 migraine attacks recorded) before starting the treatment phase with the RhinoChill Device. Treatment will be for 2 migraine attacks. Only a single treatment is allowed for the first attack, but on the second attack the patient may deliver 2 treatments with a gap of at least 2 hours between treatments.
REC name
North West - Preston Research Ethics Committee
REC reference
15/NW/0126
Date of REC Opinion
16 Mar 2015
REC opinion
Favourable Opinion