Tegeler Catherine L, Munger Clary Heidi, Shaltout Hossam A, Simpson Sean L, Gerdes Lee, Tegeler Charles H
Department of Neurology, Wake Forest School of Medicine (WFSM), Winston-Salem, NC, USA.
Hypertension and Vascular Research Center, WFSM, Winston-Salem, NC, USA.
Glob Adv Integr Med Health. 2023 Jan 18;12:27536130221147475. doi: 10.1177/27536130221147475. eCollection 2023 Jan-Dec.
Interventions for insomnia that also address autonomic dysfunction are needed.
We evaluate Cereset Research™ Standard Operating Procedures (CR-SOP) in a pilot randomized, controlled trial. CR-SOP is a less operator-dependent, more generalizable innovation of HIRREM, a noninvasive, closed-loop, allostatic, acoustic stimulation neurotechnology demonstrated to improve insomnia and autonomic function.
Adults with Insomnia Severity Index (ISI) scores of ≥8 were randomized to receive ten sessions of CR-SOP, with tones linked to brainwaves (LB, intervention), or a sham condition of random tones not linked to brainwaves (NL, control). Measures were collected at enrollment and 0-14 days and 4-6 weeks post-allocated intervention. The primary outcome was differential change in ISI from baseline to 4-6 weeks post-intervention. Secondary self-report measures assessed sleep quality65 and behavioral outcomes. Ten-minute recordings of heart rate and blood pressure were collected to analyze autonomic function (heart rate variability [HRV] and baroreflex sensitivity).
Of 22 randomized, 20 participants completed the allocated condition. Intention to treat analysis of change from baseline to the 4-6 week outcome demonstrated mean ISI score reduction of 4.69 points among controls (SE 1.40). In the intervention group, there was an additional 2.58 point reduction in ISI score (SE 2.13; total reduction of 7.27, = .24). Sleep quality and some measures of autonomic function improved significantly among the intervention group compared to control.
This pilot study compared use of a standardized, allostatic, acoustic neurotechnology intervention with a sham, active control condition. The magnitude of change in insomnia severity was clinically relevant and similar to the findings in a prior, fully powered trial, but the differential improvement observed was not statistically significant. Significant improvements were demonstrated in sleep quality and some autonomic function measures.
需要有针对失眠且能解决自主神经功能障碍的干预措施。
我们在一项初步随机对照试验中评估Cereset Research™标准操作程序（CR-SOP）。CR-SOP是HIRREM的一种较少依赖操作人员、更具普遍性的创新技术，HIRREM是一种无创、闭环、适应性、声学刺激神经技术，已被证明可改善失眠和自主神经功能。
失眠严重程度指数（ISI）得分≥8的成年人被随机分配接受10次CR-SOP治疗，其中音调与脑电波相关（LB，干预组），或接受与脑电波无关的随机音调的假治疗（NL，对照组）。在入组时以及分配干预后0 - 14天和4 - 6周收集测量数据。主要结局是从基线到干预后4 - 6周ISI的差异变化。次要的自我报告测量评估睡眠质量和行为结局。收集10分钟的心率和血压记录以分析自主神经功能（心率变异性[HRV]和压力反射敏感性）。
22名随机分组的参与者中，20名完成了分配的治疗。意向性分析显示，从基线到4 - 6周结局，对照组的ISI平均得分降低了4.69分（标准误1.40）。在干预组中，ISI得分额外降低了2.58分（标准误2.13；总降低7.27分，P = 0.24）。与对照组相比，干预组的睡眠质量和一些自主神经功能指标有显著改善。
这项初步研究将标准化的适应性声学神经技术干预与假治疗的积极对照条件进行了比较。失眠严重程度的变化幅度具有临床相关性，与之前一项样本量充足的试验结果相似，但观察到的差异改善无统计学意义。在睡眠质量和一些自主神经功能指标方面有显著改善。
