失眠诊疗,有这些新进展;但美国在研的54项基金,显然更关注这个问题(2024)

学术   2024-11-01 06:31   美国  

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失眠(Insomnia,是一种常见的睡眠障碍,影响人们入睡或保持睡眠。患者可能难以入睡,或者夜间醒来后难以再次入睡,以及早醒等现象。

在失眠研究领域,近年来出现了多项新的诊断和治疗进展:

  1. 数字化疗法:数字化认知行为疗法(dCBT-I)通过手机应用和在线平台,为失眠患者提供方便的治疗选择。这种方法提高了治疗的可及性,特别适用于无法定期面访的患者。

  2. 新型药物:一些新药物,如食欲素受体拮抗剂(如苏沃雷生),已经被批准用于治疗失眠。这类药物通过调节大脑中的觉醒通路,促进睡眠且副作用较少。

  3. 神经调控技术:非侵入性的神经调控方法,如经颅磁刺激(TMS)和经颅直流电刺激(tDCS),被用于研究和治疗失眠。这些技术通过调节大脑活动,可能改善睡眠质量。

  4. 生物标志物研究:科学家正在寻找与失眠相关的生物标志物,以实现更精准的诊断和个性化治疗。这包括基因、炎症指标和脑电图模式等方面的研究。


尽管近年来在失眠的诊断和治疗方面取得了显著进展,但仍存在一些重要而未解决的临床问题:

  • 个体差异:失眠的原因多种多样,包括压力、焦虑、环境因素、生理疾病等,治疗需要针对具体原因,但并不是所有患者的原因都能清晰识别。
  • 长期效果:目前常见的治疗方法如行为疗法、药物治疗等在短期内有效,但对于长期效果仍存在争议,特别是药物治疗可能导致依赖性和耐药性。
  • 安全性和副作用:常用的失眠药物如苯二氮卓类药物和非苯二氮卓类药物,虽然普遍用于治疗失眠,但可能带来诸如昼间嗜睡、记忆问题等副作用。
  • 综合治疗方法:失眠往往与其他精神健康问题如抑郁、焦虑共病,需要综合性治疗方案,而目前这方面的研究和实践还不充分。
综合治疗失眠的方法需要考虑病因、患者个体差异以及可能的长期治疗计划,未来研究需要开发更为安全、有效且可持续的治疗方法,以改善患者的生活质量。

我们仅对美国国立卫生研究院(NIH)资助的在研失眠相关项目进行梳理,希望给同仁们的选题思路提供一点启发。
2024年,以Insomnia为检索词、在题目中进行检索,美国NIH针对失眠的在研有54项
我们会发现,美国基因同样从“病因学分型”开始,对失眠这个症状进行发生机制的区分,并针对性采取不同的诊疗措施。

一,谁获得了这些研究?

1,在研失眠基金最多的PI
  • JOHNS HOPKINS UNIVERSITY 的 HUHN, ANDREW S
  • PENNSYLVANIA STATE UNIV HERSHEY MED CTR 的 VGONTZAS, ALEXANDROS N
  • UNIVERSITY OF PENNSYLVANIA 的 GEHRMAN, PHILIP RICHARD
  • UNIVERSITY OF SOUTH FLORIDA 的 MCCRAE, CHRISTINA S
  • VIRGINIA COMMONWEALTH UNIVERSITY 的 MARTIN, CAITLIN EILEEN


2,失眠基金最多的研究机构
  • 约翰霍普金斯大学

  • 弗吉尼亚联邦大学

  • 宾夕法尼亚州立大学赫尔希医学中心

  • 加州大学旧金山分校

  • 密歇根大学安娜堡分校



二,失眠研究热点是什么?

失眠研究领域总览(根据关键词)


失眠研究大的方向包括老年人(Older Adults)、初级护理(Primary Care)、PTSD、失眠表型(Insomnia Phenotypes)、睡眠持续时间(Sleep Duration)、一线治疗(Firstline Treatment)等。

三,借鉴与突破

我们也分享在失眠领域的几项课题摘要,希望对同仁们有所启发。
A,Phase III double-blind, randomized controlled trial of suvorexant versus placebo to treat insomnia in persons with opioid use disorder
The proposed study is an FDA-regulatory-grade Phase III multisite randomized-controlled trial of suvorexant versus placebo in persons with insomnia who are utilizing long-term MOUD treatment. Participants who are prescribed buprenorphine or methadone for OUD will be screened to determine study eligibility. 
Eligible individuals will be enrolled for an 8-week study that includes the following conditions: one night double-dummy placebo lead-in prior to randomization; ~8 weeks of suvorexant or placebo where the dose may be escalated from 10 mg to 20 mg after 3 nights (consistent with current suvorexant label instructions); and two-nights double-dummy placebo lead-out to examine discontinuation effects. In lab polysomnography (PSG) will be used to at the beginning and end of the trial to determine the primary endpoint of change from baseline total sleep time. Adverse events and other indicators of patient safety will be monitored throughout the study. Participants will also be assessed for OUD treatment outcomes including regular urine toxicology and trajectories of mental health during the study. 
Specific Aims of the study are to (Aim 1) evaluate the efficacy of suvorexant versus placebo in treat insomnia in persons taking buprenorphine or methadone for OUD treatment, (Aim1) Evaluate the safety of suvorexant versus placebo in persons taking buprenorphine or methadone for OUD treatment, (Aim 3) submit a Supplement Application of Efficacy to the FDA to support an update to the label of suvorexant, and (Exploratory Aim 4) determine whether suvorexant versus placebo improves OUD treatment outcomes. 
The results of this important study will inform treatment providers on whether suvorexant is safe and effective for insomnia in persons with OUD, and exploratory results will further our scientific understanding of the role of the orexin system in OUD treatment and recovery.

B, Multicenter Randomized Controlled Trial of Brief Behavioral Therapy for Cancer Related Insomnia

Background: Sleep disturbances, particularly insomnia, are prevalent in cancer patients undergoing chemotherapy. Our clinically based Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI) is a new approach for treating insomnia symptoms during cancer care and can serve as a model for other behavioral interventions during medical treatment. Our design allows us to capture patients just as they are developing insomnia symptoms, but before their problems become chronic and require more intensive intervention. Our behavioral intervention is innovative because we can deliver it in tandem with patients’ biomedical treatments, at the bedside, which significantly reduces patient burden. BBT-CI is a brief (2 face-to-face meetings, four 15-minute phone calls), feasible and acceptable intervention that has shown promise in reducing insomnia and other cancer-related side effects and in improving circadian rhythms at four community oncology clinic sites. 

Methods: The proposed project will test the efficacy of a novel BBT-CI in multiple private practice clinical oncology settings (n=20) across the country through the University of Rochester Cancer Center NCI Community Oncology Research Program (NCORP). We propose to randomize 400 cancer patients receiving chemotherapy to either BBT-CI or Healthy EAting Education Learning for healthy sleep (HEAL). Our HEAL control condition has been tested in our preliminary trial and is matched to BBT-CI for time and attention while excluding active components of the BBT-CI intervention (i.e., stimulus control, physical activity, circadian entrainment). 

The proposed innovative study will: 1) test the efficacy of a novel BBT-CI intervention in a community setting (NCORP network), 2) train nurses and clinical assistants to deliver the intervention in the infusion clinic, making it easier to disseminate in the future, and 3) elucidate the psychophysiology of insomnia and treatment response by collecting physiological circadian and autonomic nervous system markers. The proposed study aims to change the paradigm of how behavioral treatments can be delivered by creating and delivering the intervention in tandem with acute cancer care.


天下科研,唯快不破。
看了上述检索结果,对您有什么启发?赶快行动吧。

作者:Amber Wang;助理:ChatGPT;编辑:Jessica,微信号:Healsanq,加好友请注明理由。
美国Healsan Consulting(恒祥咨询)于2016年创建于美国首都大华府地区,专长于Healsan医学大数据分析(Healsan™)、及基于大数据的Hanson临床科研培训(HansonCR™)和医学编辑服务(MedEditing™)。主要为医生科学家、生物制药公司和医院科研处等提供分析和报告,成为诸多机构的“临床科研外挂”。
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