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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References
Hughes JM, Ulmer CS, Gierisch JM, Nicole Hastings S, Howard MO (2018) Insomnia in United States military veterans: an integrated theoretical model. Clin Psychol Rev 59:118–125
Mysliwiec V et al (2020) The management of chronic insomnia disorder and obstructive sleep apnea: synopsis of the 2019 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guidelines. Ann Intern Med
Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M (2008) Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med 4(5):487–504
Lader M (2011) Benzodiazepines revisited—will we ever learn? Addiction 106(12):2086–2109
Nofzinger EA, Buysse DJ, Germain A, Price JC, Miewald JM, Kupfer DJ (2004) Functional neuroimaging evidence for hyperarousal in insomnia. Am J Psychiatry 161(11):2126–2128
Nofzinger EA, Buysse DJ, Miewald JM, Meltzer CC, Price JC, Sembrat RC, Ombao H, Reynolds CF, Monk TH, Hall M, Kupfer DJ, Moore RY (2002) Human regional cerebral glucose metabolism during non-rapid eye movement sleep in relation to waking. Brain 125(Pt 5):1105–1115
Nofzinger E et al Frontal cerebral hypothermia: a new approach to the treatment of insomnia. Sleep
Roth T et al (2018) A novel forehead temperature-regulating device for insomnia: a randomized clinical trial. Sleep 41(5)
Yang M, Morin CM, Schaefer K, Wallenstein GV (2009) Interpreting score differences in the Insomnia Severity Index: using health-related outcomes to define the minimally important difference. Curr Med Res Opin 25(10):2487–2494
Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL (2015) The posttraumatic stress disorder checklist for DSM-5 (PCL-5): development and initial psychometric evaluation. J Trauma Stress 28(6):489–498
Keane TM, Fairbank JA, Caddell JM, Zimering RT, Taylor KL, Mora CA (1989) Clinical evaluation of a measure to assess combat exposure. Psychol Assess 1(1):53–55
Saunders JB et al (1993) Development of the alcohol use disorders identification test (AUDIT): WHO collaborative project on early detection of persons with harmful alcohol consumption-II. Addiction 88(6):791–804
Donnelly KT, Donnelly JP, Dunnam M, Warner GC, Kittleson CJ, Constance JE, Bradshaw CB, Alt M (2011) Reliability, sensitivity, and specificity of the VA traumatic brain injury screening tool. J Head Trauma Rehabil 26(6):439–453
Kroenke K, Spitzer RL, Williams JB (2001) The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 16(9):606–613
Spitzer RL, Kroenke K, Williams JBW, Löwe B (2006) A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med 166(10):1092–1097
Monk TH et al (1994) The Pittsburgh sleep diary. J Sleep Res 3(2):111–120
Germain A, Hall M, Krakow B, Katherine Shear M, Buysse DJ (2005) A brief sleep scale for posttraumatic stress disorder: Pittsburgh Sleep Quality Index Addendum for PTSD. J Anxiety Disord 19(2):233–244
Lichstein KL, Durrence HH, Taylor DJ, Bush AJ, Riedel BW (2003) Quantitative criteria for insomnia. Behav Res Ther 41(4):427–445
Morin CM, Belleville G, Bélanger L, Ivers H (2011) The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep 34(5):601–608
Smith MT, Perlis ML, Park A, Smith MS, Pennington JM, Giles DE, Buysse DJ (2002) Comparative meta-analysis of pharmacotherapy and behavior therapy for persistent insomnia. Am J Psychiatry 159(1):5–11
Karlin BE, Trockel M, Taylor CB, Gimeno J, Manber R (2013) National dissemination of cognitive behavioral therapy for insomnia in veterans: therapist- and patient-level outcomes. J Consult Clin Psychol 81(5):912–917
Wu JQ, Appleman ER, Salazar RD, Ong JC (2015) Cognitive behavioral therapy for insomnia comorbid with psychiatric and medical conditions: a meta-analysis. JAMA Intern Med 175(9):1461–1472
Drake CL et al (2019) Treating chronic insomnia in postmenopausal women: a randomized clinical trial comparing cognitive-behavioral therapy for insomnia, sleep restriction therapy, and sleep hygiene education. Sleep 42(2)
Dutschmann M, Herbert H (1996) The Kolliker-Fuse nucleus mediates the trigeminally induced apnoea in the rat. Neuroreport 7(8):1432–1436
Panneton WM, Gan Q, Juric R (2010) The rat: a laboratory model for studies of the diving response. J Appl Physiol (1985) 108(4):811–820
Ulmer CS et al (2018) Posttraumatic stress disorder diagnosis is associated with reduced parasympathetic activity during sleep in US veterans and military service members of the Iraq and Afghanistan wars. Sleep 41(12)
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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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).
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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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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 25, 441–448 (2021). https://doi.org/10.1007/s11325-020-02126-w
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DOI: https://doi.org/10.1007/s11325-020-02126-w