A novel forehead temperature-regulating device for insomnia: a randomized clinical trial.
A novel forehead temperature-regulating device for insomnia: a randomized clinical trial.
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一种治疗失眠的新型前额温度调节装置：一项随机临床试验。
DOI：
10.1093/sleep/zsy045
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发表时间：
2018
期刊：
影响因子：
5.6
通讯作者：
Nofzinger,Eric
中科院分区：
文献类型：
--
作者：
Roth,Thomas;Mayleben,David;Feldman,Neil;Lankford,Alan;Grant,Timothy;Nofzinger,Eric
研究目的失眠是普通人群中最常见的疾病之一。催眠药物是有效的，但它们的使用受到不良事件(AEs)的限制。这项研究评估了一种新型额部温度调节装置的安全性和有效性，该装置提供额部大脑热疗(维持在14-16°C，相当于57-61°F)，用于治疗失眠。方法这是一项前瞻性随机对照试验，涉及106名被诊断为失眠的成年人，治疗两个晚上。主要观察指标包括持续睡眠的潜伏期和多导睡眠图(PSG)记录的睡眠效率，以及AES的频率和严重程度。结果安全性与假治疗相当。在测量持续睡眠的绝对潜伏期(p=0.092)或绝对睡眠效率的两个先验共同主要终点中，没有发现统计学上的显着差异。与Sham相比，额叶热疗在其他收敛的睡眠潜伏期指标上都有改善，包括从基线到持续睡眠潜伏期的相对变化(p=0.013)，到阶段1非快速眼动睡眠的潜伏期(p=0.006)，到阶段2非快速眼动睡眠的潜伏期(p=0.002)，到阶段3非快速眼动睡眠的潜伏期趋势(p=0.055)，以及夜间1小时内睡眠分钟数的增加(p=0.024)。结论两夜额叶脑热疗改善了失眠症患者入睡能力的多导睡眠图测量，且具有良好的安全性。有必要进行进一步的研究，以确定这种疗法在长期治疗失眠中的作用。试验注册临床试验.gov标识：NCT01966211
Study ObjectivesInsomnia is one of the most common disorders in the general population. Hypnotic medications are efficacious, but their use is limited by adverse events (AEs). This study evaluated the safety and efficacy of a novel forehead temperature-regulating device that delivers frontal cerebral thermal therapy (maintained at 14–16°C, equivalent to 57–61°F) for the treatment of insomnia.MethodsThis was a prospective, randomized controlled trial involving two nights of therapy in 106 adults diagnosed with insomnia. The main outcome measures included latency to persistent sleep and sleep efficiency derived from polysomnographic (PSG) recordings and frequency and severity of AEs.ResultsThe safety profile was comparable to sham treatment. Statistically significant differences were not found in the two a priori co-primary endpoint measures absolute latency to persistent sleep (p= 0.092) or absolute sleep efficiency. Frontal cerebral thermal therapy produced improvements over sham in other convergent measures of sleep latency including relative changes from baseline in latency to persistent sleep (p= 0.013), the latency to stage 1 NREM sleep (p= 0.006), the latency to stage 2 NREM sleep (p= 0.002), a trend for the latency to stage 3 NREM sleep (p= 0.055), and an increase in the minutes of sleep during the first hour of the night (p= 0.024).ConclusionsTwo-night frontal cerebral thermal therapy produced improvements in PSG measures of insomnia patients’ ability to fall asleep and had a benign safety profile. Further studies are warranted to determine the role of this therapy in the longer-term management of insomnia.Trial Registrationclinicaltrials.gov Identifier: NCT01966211