Pasche B, Erman M, Hayduk R, Mitler M M, Reite M, Higgs L, Kuster N, Rossel C, Dafni U, Amato D, Barbault A, Lebet J P
Symtonic USA, Inc., New York, New York 10162, USA.
Sleep. 1996 May;19(4):327-36. doi: 10.1093/sleep/19.4.327.
The treatment of chronic psychophysiological insomnia presents a challenge that has not been met using currently available pharmacotherapy. Low energy emission therapy (LEET) has been developed as a potential alternative therapy for this disorder. LEET consists of amplitude-modulated electromagnetic fields delivered intrabuccally by means of an electrically conducting mouthpiece in direct contact with the oral mucosa. The effect of LEET on chronic psychophysiological insomnia was assessed with polysomnography (PSG) and sleep rating forms on a total of 106 patients at two different centers. Active or inactive LEET was administered for 20 minutes in late afternoon three times a week for a total of 12 treatments. Primary efficacy endpoints evaluating the results were changes from baseline in PSG-assessed total sleep time (TST) and sleep latency (SL). Secondary endpoints were changes in sleep efficiency (SE), sleep stages, and reports by the subjects of SL and TST. There was a significant increase in TST as assessed by PSG between baseline and post-treatment values for the active treatment group (76.0 +/- 11.1 minutes, p = 0.0001). The increase for the inactive treatment group was not statistically significant. The TST improvement was significantly greater for the active group when compared to the inactive group (adjusted for baseline TST; p = 0.020. R1 = 0.20). There was a significant decrease in SL as assessed by PSG between baseline and post-treatment values for the active treatment group (-21.6 +/- 5.9 minutes, p = 0.0006), whereas the decrease noted for the inactive treatment group was not statistically significant. The difference in SL decrease between the two treatment groups was marginally significant (adjusted for baseline SL and center, p = 0.068, R2 = 0.60). The number of sleep cycles per night increased by 30% after active treatment (p = 0.0001) but was unchanged following inactive treatment. Subjects did not experience rebound insomnia, and there were no significant side effects. The data presented in this report indicate that LEET administered for 20 minutes three times a week increased TST and reduced SL in chronic psychophysiological insomnia. LEET is safe and well tolerated and it effectively improved the sleep of chronic insomniacs given 12 treatments over a 4-week period by increasing the number of sleep cycles without altering the percentage of the various sleep stages during the night. The therapeutic action of LEET differs from that of currently available drug therapies in that the sleep pattern noted in insomniacs following LEET treatment more closely resembles nocturnal physiological sleep. This novel treatment may offer an attractive alternative therapy for chronic insomnia.
慢性心理生理性失眠的治疗是一项挑战，目前可用的药物疗法尚未解决这一问题。低能量发射疗法（LEET）已被开发为治疗这种疾病的一种潜在替代疗法。LEET由通过与口腔黏膜直接接触的导电口器经口腔内递送的调幅电磁场组成。在两个不同中心，使用多导睡眠图（PSG）和睡眠评分表对总共106名患者评估了LEET对慢性心理生理性失眠的影响。每周三次在傍晚给予主动或非主动LEET治疗20分钟，共进行12次治疗。评估结果的主要疗效终点是PSG评估的总睡眠时间（TST）和睡眠潜伏期（SL）相对于基线的变化。次要终点是睡眠效率（SE）、睡眠阶段的变化，以及受试者关于SL和TST的报告。主动治疗组治疗后与基线相比，PSG评估的TST有显著增加（76.0±11.1分钟，p = 0.0001）。非主动治疗组的增加无统计学意义。与非主动组相比，主动组的TST改善显著更大（根据基线TST进行调整；p = 0.020，R1 = 0.20）。主动治疗组治疗后与基线相比，PSG评估的SL有显著降低（-21.6±5.9分钟，p = 0.0006），而非主动治疗组的降低无统计学意义。两组治疗后SL降低的差异边缘显著（根据基线SL和中心进行调整，p = 0.068，R2 = 0.60）。主动治疗后每晚的睡眠周期数增加了30%（p = 0.0001），而非主动治疗后未改变。受试者未出现反弹性失眠，也没有明显的副作用。本报告中的数据表明，每周三次给予20分钟的LEET可增加慢性心理生理性失眠患者的TST并缩短SL。LEET安全且耐受性良好，通过增加睡眠周期数，在4周内给予12次治疗，有效改善了慢性失眠患者的睡眠，且未改变夜间各睡眠阶段的百分比。LEET的治疗作用与目前可用的药物疗法不同，在于LEET治疗后失眠患者的睡眠模式更接近夜间生理睡眠。这种新型治疗方法可能为慢性失眠提供一种有吸引力的替代疗法。
