While forehead cooling has been studied in patients with insomnia in the absence of comorbid medical/psychiatric disorders, it has never been evaluated in patients with insomnia in the presence of co-morbid medical/psychiatric disorders.
Veterans with chronic insomnia disorder and co-morbid medical and psychiatric conditions received 4-week open-label, in-home, nightly treatment with a forehead cooling device (14–16 °C) along with personalized sleep hygiene following baseline assessments. Pre- and post-treatment, participants completed the Insomnia Severity Index (ISI), the Generalized Anxiety Disorder 7-item scale (GAD-7), and the Patient Health Questionnaire 9-item scale (PHQ-9). Participants recorded daily sleep and anxiety/arousal symptoms.
Of 24 veterans (20 men, 42.2 ± 9.5 years), 17 (71%) had marked insomnia severity improvement (a decrease of > 8 on the ISI) and 10 (42%) participants scored 7 or below on the ISI at post-treatment reflecting remission. Participants reported reductions in sleep onset latency (SOL) (F = 12.9, p < 0.001), and wakefulness after sleep onset (WASO) (F = 8.4, p < 0.001) across treatment. They also had significant reductions in insomnia severity (t = 10.04, p < 0.001), anxiety (t = 3.59, p = 0.002), and depression (t = 7.75, p < 0.001) from pre- to post-treatment.
This pilot study shows that 4-week nightly use of a forehead cooling device produces improvements in insomnia, anxiety, and depressive symptoms in veterans with chronic insomnia disorder and co-morbid medical and psychiatric conditions. Controlled studies are warranted to determine the role of this therapy in the management of insomnia in veterans.
Not required as a small sample size feasibility study.
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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 the staff at Ebb Therapeutics, Inc. who developed the devices for use in the study, ensured that participants received their devices, and were available to troubleshoot any specific device-related questions that arose from participants and staff and provided sleep education to participants as needed. Finally, we thank the participants for allowing us to work with them on this study.
This study was funded by Ebb Therapeutics.
Conflict of interest
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. Drs Neylan and Mysliwiec have received research funding unrelated to this work (TCN: VA: RX001939; NIMH: R01MH115020; NIA: R01AG060477; R01AG064314).
This study was approved by Campos Research and was performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.
Consent to participate
All subjects provided informed consent prior to their inclusion in the study.
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No individuals are identified in this report.
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Mysliwiec, V., Neylan, T.C., Chiappetta, L. et al. Effects of a forehead cooling device in veterans with chronic insomnia disorder and co-morbid medical and psychiatric conditions: a pilot study. Sleep Breath (2020). https://doi.org/10.1007/s11325-020-02126-w