Effects of forehead cooling and supportive care on menopause-related sleep difficulties, hot flashes and menopausal symptoms: a pilot study.

Objective/Background This pilot study explored the efficacy of a novel forehead cooling device for perceived sleep difficulties and hot flashes in menopausal-age women. Participants 20 women (55.1 +/- 4.2 years; 19 post-menopausal) with insomnia symptoms and self-reported two or more hot flashes per day. Methods Participants completed daily assessments of sleep and hot flashes (via diaries) across 1 baseline week and 4 weeks of open-label, in-home, nightly treatment with a forehead cooling device (15-18 degrees C) along with sleep hygiene instructions. They also completed ratings of insomnia and menopausal symptoms using standardized questionnaires. Results Women reported reductions in sleep onset latency (SOL), wakefulness after sleep onset (WASO), and nocturnal hot flash severity during the first week of treatment (SOL: 25.7 +/- 18.4 min; WASO: 36.3 +/- 27.3 min; hot flash severity: 3.0 +/- 2.8) compared with baseline (SOL: 38 +/- 26.3 min; WASO: 52.2 +/- 35.6 min; hot flash severity: 6.8 +/- 3.7), with further improvements after 2-4 weeks of use (p< .001). There were also clinically meaningful reductions in insomnia severity and hot flash-related daily interference and lower psychological and physical symptom scores on the Greene climacteric scale after treatment (all p's<0.001). Conclusions This exploratory, naturalistic, pilot study shows that nightly use of a forehead cooling device produces improvements in self-reported sleep and reductions in insomnia, hot flash, and other menopausal, symptoms. Controlled studies are warranted to determine the role of this therapy in the management of sleep difficulties and menopausal symptoms in women. Further mechanistic studies are needed to understand the physiological impact of forehead cooling on sleep and menopausal symptoms.