Safety and tolerability of transnasal evaporative cooling for the acute treatment of migraine in an at-home setting: A randomized, double-blind, sham-controlled, decentralized clinical trial.

Transnasal evaporative cooling (TNEC) may help manage migraine symptoms. This study assessed TNEC's safety and tolerability in adults with migraine. It took place in the U.S. from November 2023 to June 2024. Participants aged 18-65 were randomized into treatment groups. They received either active TNEC at varying flow rates or a sham control. The study involved 137 participants, with a mean age of 39 years. Most participants were female, and many were White. Adverse events were mild, including rhinorrhea and nasal irritation. Importantly, no participants discontinued treatment due to discomfort. At two hours posttreatment, 70% of participants receiving TNEC at 10 L/min reported pain relief. This was significantly higher compared to the sham group. TNEC was safe and well-tolerated, showing promise for future clinical trials. Larger studies are needed to confirm these findings and explore efficacy further. Clinical relevance: This research indicates that TNEC may offer a safe, at-home treatment option for migraine relief.