Effects of a forehead cooling device in veterans with chronic insomnia disorder and co-morbid medical and psychiatric conditions: a pilot study

Abstract

Purpose

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.

Methods

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.

Results

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.

Conclusion

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.

Trial registration

Not required as a small sample size feasibility study.

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Fig. 1

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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 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.

Funding

This study was funded by Ebb Therapeutics.

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All authors whose names appear on the submission:

(1) made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data;

(2) drafted the work or revised it critically for important intellectual content;

(3) approved the version to be published; and

(4) agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Corresponding author

Correspondence to Eric A. Nofzinger.

Ethics declarations

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).

Ethics approval

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.

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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

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Keywords

  • Insomnia
  • Veterans
  • Device
  • Therapy