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

ABSTRACT

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°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.

Acknowledgments

The authors gratefully acknowledge the contributions of the staff at Campos Research, Pittsburgh, PA who recruited and screened participants and ensured completion of all measures across the study. We thank Laurel Chiappetta M.S. for providing data analysis and statistical support. We thank the staff at Ebb Therapeutics, Inc. who developed the devices for use in the study, ensured that participants received their devices, troubleshooted any specific device-related questions that arose from participants and staff and provided sleep education to subjects as needed. Finally, we thank the participants for allowing us to work with them on this study.

Disclosure statement

Dr. Nofzinger is the Inventor, Founder and Chief Medical Officer of Ebb Therapeutics, the company that developed and is commercializing the forehead cooling device used in this study. Ebb Therapeutics provided funding for this research. Drs Baker and de Zambotti have received research funding unrelated to this work from Ebb Therapeutics Inc., Fitbit Inc., International Flavors & Fragrances Inc., Noctrix Health, Inc.

Additional information

Funding

This work was supported by the Ebb Therapeutics.