A novel forehead temperature-regulating device for insomnia: a randomized clinical trial.

Study Objectives: Insomnia is one of the most common disorders in the general population. Hypnotic medications are efficacious, but their use is limited by adverse events (AEs). This study evaluated the safety and efficacy of a novel forehead temperature-regulating device that delivers frontal cerebral thermal therapy (maintained at 14-16°C, equivalent to 57-61°F) for the treatment of insomnia. Methods: This was a prospective, randomized controlled trial involving two nights of therapy in 106 adults diagnosed with insomnia. The main outcome measures included latency to persistent sleep and sleep efficiency derived from polysomnographic (PSG) recordings and frequency and severity of AEs. Results: The safety profile was comparable to sham treatment. Statistically significant differences were not found in the two a priori co-primary endpoint measures absolute latency to persistent sleep (p = 0.092) or absolute sleep efficiency. Frontal cerebral thermal therapy produced improvements over sham in other convergent measures of sleep latency including relative changes from baseline in latency to persistent sleep (p = 0.013), the latency to stage 1 NREM sleep (p = 0.006), the latency to stage 2 NREM sleep (p = 0.002), a trend for the latency to stage 3 NREM sleep (p = 0.055), and an increase in the minutes of sleep during the first hour of the night (p = 0.024). Conclusions: Two-night frontal cerebral thermal therapy produced improvements in PSG measures of insomnia patients' ability to fall asleep and had a benign safety profile. Further studies are warranted to determine the role of this therapy in the longer-term management of insomnia. Trial Registration: clinicaltrials.gov Identifier: NCT01966211.