0514 Efficacy of a Forehead-Cooling Device for Treating Insomnia in Veterans
Abstract Introduction In 2 independent studies, we explored whether a forehead-cooling device was effective in improving insomnia in veterans. Methods Both studies were uncontrolled and exploratory in nature. The first study involved 20 veterans who expressed interest in using the forehead-cooling device and received 4 weeks treatment. The second study involved 19 veterans who were recruited via media to participate in a 4-week study and were compensated for their participation. All participants completed questionnaires before and after treatment. Results In the retrospective analysis, veterans had improvements over baseline in insomnia severity index (M ± SD =17.6 ± 4.7 pre- vs 6.9 ± 3.5 post-treatment, t(19) = -9.4, p<0.00001), in sleep latency (M ± SD = 61.7 ± 49.1 minutes pre- vs 25.0 ± 20.8 minutes post-treatment, t(19) = -4.6, p<0.001) and in minutes awake after sleep onset (M ± SD =78.7 ± 57.8 minutes pre- vs 29.9 ± 18.3 minutes post-treatment, t(19) = -4.0, p<0.001). In the prospective study, veterans had improvements in insomnia severity index over baseline (M ± SD = 20.7 +3.8 pre- vs 9.5 ± 7.5 post-treatment, t(18) = 5.8, p<0.00001), depression severity on the PHQ-9 (M ± SD = 21.5 ±6.1 pre- vs 14.2 ± 5.1 post-treatment, t(18) =4.1, p<0.001) and anxiety severity on the GAD 7 (M ± SD = 9.8 ±7.1 pre- vs. 6.2 ± 5.4 post-treatment, t(18) = -3.1, p<0.01). Conclusion Use of a forehead-cooling device improved insomnia in veterans. These findings were replicated in an independent prospective trial. Reductions in depressive and anxiety symptoms from baseline were also noted in the prospective study. These promising preliminary data suggest the need for further large scale randomized controlled trials to establish the efficacy of forehead-cooling on insomnia in veterans. Support Ebb Pharmaceuticals, Pittsburgh, PA 15222