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Forehead cooling has previously been shown to improve EEG sleep measures in insomnia patients when applied for 2 nights. The current study assessed the durability of these effects after 30 days in home use as well as safety over 6 months in home use. Methods This was a prospective, open label trial involving 32 adults meeting diagnostic criteria for primary insomnia who previously had participated in a 2 night in lab EEG sleep study. In the current study, participants received an additional 30 nights in home treatment, then had repeat EEG sleep studies performed to determine if effects noted at 2 nights remained durable after 30 days. Subjects also participated in an open label 6-month in-home use safety study. Results Baseline, 2-night and 30-night EEG sleep measures for sleep latency were 80.7 ± 73.8, 25.3 ± 22.6, 26.2 ±25.8 minutes (2- to 30-night difference p=0.81, NS) and for sleep efficiency were 67.4 ± 15.7, 81.4 ± 11.2, 83.2 ± 13.6 (2- to 30-night difference p=0.18, NS). Subjective sleep quality (0-100 scale with 100=best) at baseline, 2-night and 30-nights were 29.8 ± 15.2, 48.3 ± 20.2, 57.2 ± 21.1 (linear improvements significant over time p&amp;lt;0.001). No adverse effects were seen across 6-months use. Conclusion Forehead cooling demonstrated durability of effects on EEG sleep measures from 2- to 30-nights use. Continuing improvements in subjective sleep quality when measured over time from baseline assessments to the end of the 30-night in-home use period were noted. Forehead cooling was safe over 6 months use in the home as evidenced by no serious device related adverse events. Support Ebb Therapeutics, Pittsburgh, PA 15222

0515 Durability of Effects of Forehead Cooling on EEG Sleep Measures in Insomnia Patients from 2- to 30-Nights Use and 6-Month Safety Results