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.

概括 阿片类药物使用障碍（OUD）是美国迅速扩大的健康流行病，几乎没有进展 治疗效率。睡眠不足代表了这两个阶段的最严重和普遍的症状 戒断和持续的任务治疗。因为睡眠损失在焦虑和日常工作中起着关键作用，所以 破坏是OUD患者较高的缓解事件所证明的患者缓解的主要因素 患有睡眠障碍。 OUD中的睡眠功能障碍的特征是慢波睡眠（SWS）显着丧失， 这是睡眠益处的关键组成部分。在严重戒断的患者中，睡眠可能会组成 几乎完全是短暂的快速移动（REM），而稀疏的非REM（NREM）睡眠中断 通过许多觉醒。鉴于OUD睡眠质量不佳以及与退休的关联的流行率 增强睡眠宁静影响的治疗可以降低缓解速度。但是，通常 规定的睡眠药物具有镇静和催眠作用，对患者的依赖风险太大 与Oud。这是增强睡眠的新干预措施是一种至关重要的未满足的医疗需求，可能会有 对他们的生活的巨大影响。在这里，我们基于人类和动物模型的研究，表明 聚焦超声可以刺激SWS的大脑区域。我们将设计一个可穿戴设备集成 睡眠记录和可通话的超声阵列。超声阵列将针对丘脑，核心SWS 结构，使用患者大脑和头骨的MRI图。我们将设计自定义脑电图分析软件 在慢波的上升阶段传递刺激，以增强波幅度，持续时间和有益 效果。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。通过该项目，我们将与FDA互动，以获得II期研究的批准 与Oud患者。