Transcranial ultrasound device for enhancing sleep in OUD

用于增强 OUD 睡眠的经颅超声装置

• 批准号: 10390994
• 负责人: Rajiv Mahadevan
• 金额: $ 31.94万
• 依托单位: ATTUNE NEUROSCIENCES, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10390994
• 关键词: Abstinence; Acoustics; Affect; Animal Model; Animals; Anxiety; Brain; Brain region; Clinical; Clinical Research; Cognitive; Computer software; Custom; Dependence; Development; Device or Instrument Development; Devices; Dimensions; Effectiveness; Electroencephalography; Elements; Ensure; Epidemic; Focused Ultrasound; Future; Goals; Health; Helping to End Addiction Long-term; Home; Human; Incidence; Individual; Individual Differences; Intervention; Intervention Studies; Investigation; Life; MRI Scans; Magnetic Resonance Imaging; Maps; Medical; Memory; Middle Insomnia; Modeling; Nature; Opioid; Outpatients; Patients; Pharmaceutical Preparations; Pharmacology; Phase; Physicians; Physiological; Play; Population; Prevalence; Quality of life; Relapse; Research; Risk; Rodent; Role; Running; Sleep; Sleep Architecture; Sleep Deprivation; Sleep Disorders; Sleep disturbances; Sleeplessness; Slow-Wave Sleep; Stimulus; Structure; Symptoms; Temporal bone structure; Thalamic structure; Thick; Tissues; Transducers; Translating; Treatment Efficacy; Ultrasonography; United States; Vulnerable Populations; Withdrawal; Withdrawal Symptom; Work; addiction; base; behavioral pharmacology; cognitive process; commercialization; cranium; design; drug craving; human model; hypnotic; image registration; imaging Segmentation; improved; neuroregulation; new technology; non rapid eye movement; novel; opioid use disorder; persistent symptom; phase 2 study; poor sleep; prototype; rapid eye movement; relapse patients; sedative; sleep pattern; sleep quality; success; theories; tool; treatment strategy; usability; wearable device

Summary The opioid use disorder (OUD) is a rapidly expanding health epidemic in the United States with little progress in treatment efficacy. Insufficient sleep represents the most severe and pervasive symptoms of both phases of withdrawal and persist despite treatment. Because sleep loss plays a key role in anxiety and daily routine, its disruption is a major factor in a patient’s relapse evidenced by the higher incidence of relapse in OUD patients with sleep disorders. Sleep dysfunction in OUD is characterized by significant loss in slow wave sleep (SWS), which are critical components of the benefits of sleep. In patients with severe withdrawal, sleep may consist almost entirely of brief periods of rapid eye movement (REM) with sparse non-REM (NREM) sleep interrupted by numerous awakenings. Given the prevalence of poor sleep quality in OUD and the association with relapse, treatments enhancing the restful effects of sleep could reduce the rate of relapse. However, commonly prescribed sleep medications have sedative and hypnotic effects with a risk of dependency too great for patients with OUD. Thus, new interventions to augment sleep are a critical unmet medical need which could have an outsized influence on their life. Here, we build off of research in humans and animal models demonstrating that focused ultrasound can stimulate brain regions underlying SWS. We will design a wearable device integrating sleep recordings and steerable ultrasound arrays. Ultrasound arrays will target the thalamus, a core SWS structure, using MRI maps of patient’s brains and skulls. We will design custom EEG analytics software for delivering the stimulus during the rising phase of slow waves to enhance wave amplitude, duration, and beneficial effects. We will perform a human factors study with OUD patients to assess comfort and usability for redesigning the wearable. Throughout the project we will interact with the FDA in efforts to gain approval for a phase II study with OUD patients.

总结 阿片类药物使用障碍（OUD）是美国一种迅速蔓延的健康流行病， 治疗效果睡眠不足代表了两个阶段中最严重和最普遍的症状， 停药并持续治疗。由于睡眠不足在焦虑和日常生活中起着关键作用， 中断是患者复发的主要因素，OUD患者复发的发生率较高 有睡眠障碍OUD中的睡眠功能障碍的特征在于慢波睡眠（SWS）的显著丧失， 这是睡眠益处的关键组成部分。在严重戒断的患者中，睡眠可能包括 几乎完全是短暂的快速眼动（REM），伴有稀疏的非REM（NREM）睡眠中断 无数的觉醒。考虑到OUD患者睡眠质量差的普遍性以及与复发的相关性， 增强睡眠宁静效果的治疗可以降低复发率。然而，通常 处方的睡眠药物具有镇静和催眠作用，但对患者来说依赖性太大 关于OUD因此，增加睡眠的新干预措施是一个关键的未满足的医疗需求， 对他们的生活产生巨大影响。在这里，我们建立在人类和动物模型的研究基础上， 聚焦超声可以刺激SWS下的大脑区域。我们将设计一种可穿戴设备， 睡眠记录和可控超声阵列。超声波阵列将瞄准丘脑，一个核心SWS 使用病人大脑和头骨的MRI图来分析大脑结构。我们将设计定制的EEG分析软件， 在慢波的上升阶段期间递送刺激以增强波的振幅、持续时间，并且有益于 方面的影响.我们将对OUD患者进行人为因素研究，以评估重新设计的舒适性和可用性 可穿戴设备在整个项目中，我们将与FDA互动，努力获得II期研究的批准 OUD患者。