Department of Neurology, Wake Forest School of Medicine (WFSM), Winston-Salem, NC, USA.
Hypertension and Vascular Research Center, WFSM, Winston-Salem, NC, USA.
Brain Behav. 2020 Nov;10(11):e01826. doi: 10.1002/brb3.1826. Epub 2020 Sep 17.
Effective insomnia interventions that also address autonomic dysregulation are lacking. We evaluate high-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM ), in a randomized, controlled clinical trial. HIRREM is a noninvasive, closed-loop, allostatic, acoustic stimulation neurotechnology, to support self-optimization of brain rhythms.
One hundred and seven adults (mean age 45.7, SD ± 5.6, 73 women), with Insomnia Severity Index (ISI) scores of ≥15, received ten, 90-min sessions of HIRREM, with tones linked to brainwaves (LB, 56), or random tones not linked to brainwaves (NL, 51), as an active, sham placebo. Outcomes were obtained at enrollment (V1), 1-7 days (V2), 8-10 weeks (V3), and 16-18 weeks (V4) after intervention. Primary outcome was differential change in ISI from V1 to V3. Secondary measures assessed depression (BDI), anxiety (BAI), quality of life (EQ-5D), and a sleep diary. Ten minute recordings of HR and BP allowed analysis of heart rate variability (HRV) and baroreflex sensitivity (BRS).
Of 107 randomized, 101 completed the intervention. Intention-to-treat analysis (107) of change from V1 to V3 revealed a mean reduction of ISI in NL of -4.93 (SE ± 0.76) points, with additional, significant reduction of -2.05 points (0.74) in LB (total reduction of -6.98, p = .045). Additional reduction of -2.30 points (0.76) was still present in the LB at V4 (p = .058). Total ISI reduction from V1 to V4 was -5.90 points for NL and -7.93 points in LB. There were group differences (p < .05) for multiple HRV and BRS measures (rMSSD, SDNN, HF alpha, and Seq ALL), as well as total sleep time, sleep onset latency, and sleep efficiency. There were no serious adverse events.
Results of this controlled clinical trial showed clinically relevant reduction of insomnia symptoms with HIRREM, over, and above an active, sham control, with associated, durable improvement in autonomic cardiovascular regulation.
目前缺乏既能有效治疗失眠又能调节自主神经的干预方法。我们评估了高分辨率、关系型、共鸣式、基于脑电图的镜像（HIRREM），这是一种非侵入性、闭环、适应不良、声刺激神经技术，可支持大脑节律的自我优化。
107 名成年人（平均年龄 45.7，标准差 ±5.6，73 名女性）的失眠严重程度指数（ISI）得分≥15，接受了 10 次、每次 90 分钟的 HIRREM 治疗，其中包括与脑电波相关的音调（LB，56 次）或与脑电波无关的随机音调（NL，51 次），作为一种积极的、假的安慰剂。在干预前（V1）、1-7 天（V2）、8-10 周（V3）和 16-18 周（V4）后获得结果。主要结果是从 V1 到 V3 的 ISI 差异变化。次要测量评估了抑郁（BDI）、焦虑（BAI）、生活质量（EQ-5D）和睡眠日记。10 分钟的 HR 和 BP 记录允许分析心率变异性（HRV）和血压反射敏感性（BRS）。
在 107 名随机分组的参与者中，有 101 名完成了干预。从 V1 到 V3 的意向治疗分析（107 人）显示，NL 的 ISI 平均降低了 4.93 分（SE ± 0.76 分），LB 进一步显著降低了 2.05 分（0.74 分）（总降低 6.98 分，p = 0.045）。LB 在 V4 时仍存在 2.30 分（0.76 分）的额外降低（p = 0.058）。NL 的总 ISI 从 V1 到 V4 降低了 5.90 分，LB 降低了 7.93 分。在多个 HRV 和 BRS 指标（rMSSD、SDNN、HF alpha 和 Seq ALL）以及总睡眠时间、入睡潜伏期和睡眠效率方面，存在组间差异（p < 0.05）。没有严重的不良事件。
这项对照临床试验的结果显示，HIRREM 可显著减轻失眠症状，且效果优于积极的假对照，并伴有自主心血管调节的持久改善。
