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
Abstract
OBJECTIVES/BACKGROUND
Transnasal evaporative cooling (TNEC) is thought to modulate activity in the sphenopalatine ganglion and maxillary division of the trigeminal nerve. The safety, tolerability, and potential for therapeutic benefits of TNEC in adults with migraine have not been assessed in a fully decentralized setting. Our objectives were to determine the safety and tolerability of a TNEC device in adults with migraine and generate hypotheses for testing in studies designed to assess efficacy.
METHODS
This prospective, double-blind, sham-controlled, randomized, decentralized clinical trial was conducted in the United States between November 2023 and June 2024. Eligible adults 18-65 years of age who self-reported migraine for ≥1 year were randomized to one of three active treatment groups (4, 6, or 10 L/min of dehumidified air) or to a sham control (2 L/min of ambient air delivered intermittently for ~10% of total time). Tolerability was measured by the percentage of participants who discontinued their treatment session due to discomfort. The assessment of TNEC treatment effects was hypothesis-generating; reported p-values are nominal. The trial was registered at clinicaltrials.gov (NCT06051604).
RESULTS
Participants (N = 137) had a mean (SD) age of 39.4 (10.1) years, 79.6% (109/137) were female, and 85.4% (117/137) were White. The most common adverse events were rhinorrhea (2.2% [3/137]) and nasal irritation, ear pressure, runny nose, and sore throat (each 1.5% [2/137]).…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 137 participants or records.
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