背景:失眠是普通人群中普遍存在的健康问题,与一系列不良健康影响有关。新,有效,安全和低成本的治疗,适合长期使用,迫切需要。先前的研究表明,前庭神经电刺激(VeNS)可以改善失眠症状,然而,只有一项假对照试验对慢性失眠症患者进行。
目的:/假设:与假刺激相比,在睡眠开始之前,ModiusSleep装置重复提供的VeNS在4周内的失眠严重程度指数(ISI)评分有更好的改善。
方法:在这种双盲中,多站点,随机化,假对照研究,招募了147名中度至重度失眠(ISI≥15)的参与者,并分配了VeNS或假设备(比例为1:1),要求他们每天在家使用30分钟(每周至少5天),持续4周。
结果:4周后,与假手术组相比,VeNS治疗组的平均ISI评分降低幅度为2.26(p=0.002).在每个协议分析中,治疗组平均ISI评分下降5.8(95%CI[-6.8,-4.81],接近临床上有意义的6点降低阈值,超过一半的人实现了临床上的显着下降。此外,治疗组在SF-36(生活质量)能量/疲劳分量方面显示优于假手术组(PPp=0.004,效应大小0.26;ITTp=0.006,效应大小0.22)。
结论:Modius睡眠有可能提供可行的,非侵入性和安全的临床有意义的失眠替代治疗选择。
BACKGROUND: Insomnia is a prevalent health concern in the general population associated with a range of adverse health effects. New, effective, safe and low-cost treatments, suitable for long-term use, are urgently required. Previous studies have shown the potential of electrical vestibular nerve stimulation (VeNS) in improving insomnia symptoms, however only one sham-controlled trial has been conducted on people with chronic insomnia.
OBJECTIVE: Repeated VeNS delivered by the Modius Sleep device prior to sleep onset will show superior improvement in Insomnia Severity Index (ISI) scores over a 4-week period compared to sham stimulation.
METHODS: In this double-blinded, multi-site, randomised, sham-controlled study, 147 participants with moderate to severe insomnia (ISI≥15) were recruited and allocated a VeNS or a sham device (1:1 ratio) which they were asked to use at home for 30 min daily (minimum 5 days per week) for 4 weeks.
RESULTS: After 4 weeks, mean ISI score reduction was 2.26 greater in the VeNS treatment group than the sham group (p = 0.002). In the per protocol analysis, the treatment group had a mean ISI score decrease of 5.8 (95 % CI [-6.8, -4.81], approaching the clinically meaningful threshold of a 6-point reduction, with over half achieving a clinically significant decrease. Furthermore, the treatment group showed superior improvement to the sham group in the SF-36 (Quality of Life) energy/fatigue component (PP p = 0.004, effect size 0.26; ITT p = 0.006, effect size 0.22).
CONCLUSIONS: Modius sleep has the potential to provide a viable, non-invasive and safe clinically meaningful alternative treatment option for insomnia.