小儿 OSA 的大脑变化
2023年7月20日 更新者:Rajesh Kumar, PhD、University of California, Los Angeles
小儿阻塞性睡眠呼吸暂停的大脑变化
阻塞性睡眠呼吸暂停 (OSA) 在儿童中非常普遍,通常是由儿童的腺样体和/或扁桃体过度生长引起的。
因此,腺样体切除术(切除扁桃体和腺样体)是儿童 OSA 最常见的治疗方法,尽管根据具体情况可能只切除扁桃体或腺样体。
同样,儿童 OSA 通常与认知功能障碍和情绪问题有关,这表明大脑会因这种情况而发生变化。
然而,大脑变化、认知和情绪问题与儿童 OSA 之间的联系尚未得到彻底探索。
因此,本研究旨在检查与对照组相比以及腺样体和/或扁桃体切除前后儿童 OSA 受试者的大脑变化、认知和情绪。
这项研究希望招募 70 名年龄在 7-12 岁之间的受试者、35 名健康对照者和 35 名被诊断患有 OSA 并计划进行腺样体切除术和/或扁桃体切除术的受试者。
对照受试者将安排一次访问加州大学洛杉矶分校,而 OSA 受试者将安排两次。
第一次访问时,所有受试者都将接受认知、情绪和睡眠问卷调查以及 MRI 扫描。
那将是控制参与研究的持续时间;然而,OSA 受试者将在 6 个月后(在腺样体切除术和/或扁桃体切除术后)返回以重复相同的程序。
睡眠质量、情绪、认知和大脑图像将在 OSA 和对照组之间以及 OSA 受试者在手术前和手术后进行比较。
研究概览
详细说明
小儿阻塞性睡眠呼吸暂停 (OSA) 是一种常见的进行性综合征,伴有严重的认知、情绪和日间行为问题,以及学习成绩差,可能源于间歇性缺氧和灌注变化引起的受损神经组织。
然而,目前尚不清楚脑组织损伤是急性还是慢性,以及髓鞘是否比轴突更容易受到影响,这是理解的一个重要步骤,因为神经修复/恢复的干预措施因急性损伤与慢性损伤以及髓鞘损伤与轴突损伤而异。
此外,尚不清楚儿科 OSA 伴随的大脑变化是否会产生功能性后果,从而导致认知或情绪缺陷。
此外,间歇性缺氧会引发一系列影响内皮细胞的损伤过程,但尚不清楚儿童 OSA 患者的局部脑血流量 (CBF) 是否减少。
小儿 OSA 的治疗方法包括扁桃体切除术和/或腺样体切除术,目前尚不清楚脑组织变化、区域 CBF 和对认知挑战的神经反应是否会在治疗后得到改善。
使用基于扩散张量成像 (DTI) 和扩散峰度成像 (DKI) 的程序,可以评估急性和慢性组织变化以及轴突状态和髓鞘完整性。
区域大脑 CBF 可以通过经过验证的动脉自旋标记 (ASL) 成像进行评估,并且可以使用血氧水平依赖性 (BOLD) 功能磁共振成像 (MRI) 检查认知挑战的区域神经活动。
因此,使用 35 名初治儿科 OSA 和 35 名对照儿童,具体目标是:使用 DTI 和 DKI 措施确定未经治疗的儿童 OSA 与健康对照相比脑组织损伤的性质和类型;使用 ASL 成像识别局部大脑 CBF,以及对认知挑战的神经反应,使用 BOLD 功能性 MRI 治疗小儿 OSA 而不是健康儿童;与对照儿童相比,评估儿童 OSA 的认知(通过差异能力量表 II 和 NEPSY II)和情绪功能(通过儿童行为检查表),并检查儿童 OSA 中脑损伤与认知和情绪功能障碍之间的关系;并检查小儿 OSA 患者在腺样体扁桃体切除术后 6 个月后脑组织变化、CBF 降低和对认知挑战的神经反应改变是否逆转,以及认知和情绪体征是否改善。
总之,小儿 OSA 腺样体扁桃体切除术后脑损伤的性质和类型、区域 CBF 变化和对认知挑战的神经反应,以及脑组织变化、CBF 改变和神经反应减弱,以及情绪和认知功能是否会恢复接受检查。
评估病理特征对于评估损伤机制以及建议手术前后的干预策略至关重要。
这些发现还将有助于指导潜在的治疗方法来挽救/恢复脑组织(例如,非甾体类抗炎药)并改善 CBF,这些方法可以实施以有益于认知和情绪健康,并改善儿科 OSA 的学业成绩。
研究类型
介入性
注册 (估计的)
70
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Rajesh Kumar, PhD
- 电话号码:310-206-1679
- 邮箱:rkumar@mednet.ucla
研究联系人备份
- 姓名:Bhaswati Roy, PhD
- 电话号码:310-825-1808
- 邮箱:broy@mednet.ucla.edu
学习地点
-
-
California
-
Los Angeles、California、美国、90095
- 招聘中
- UCLA
-
接触:
- Rajesh Kumar, PHD
- 电话号码:310-825-1808
- 邮箱:rkumar@mednet.ucla.edu
-
接触:
- Megan Carrier, MSHA
- 电话号码:303-801-8961
- 邮箱:mcarrier@mednet.ucla.edu
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首席研究员:
- Rajesh Kumar, PhD
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
7年 至 12年 (孩子)
接受健康志愿者
是的
描述
纳入标准:
OSA
- 小儿 OSA 受试者的年龄范围为 7-12 岁(将选择年龄上限和下限以避免与发育相关的脑部变化和脑部 MRI 麻醉的潜在要求)
- 在睡眠实验室通过夜间多导睡眠图诊断出至少中度 OSA(AHI > 5 次事件/小时)
- 无肥胖(年龄和性别的 BMI ≥ 95%)以避免围手术期问题
- 没有治疗呼吸状况
- 正在接受腺样体扁桃体切除术。
控制对象
- 健康的孩子
- 7-12岁(±3个月以内)
- 儿童 OSA 的性别和 BMI 匹配 (±2 kg/m2)
- 没有治疗脑部疾病的药物
- 没有任何诊断的神经系统疾病
排除标准:
- 既往有精神疾病诊断史(抑郁症和其他可能引起脑损伤的脑部疾病)
- 囊性纤维化、脑震荡和脑部占位性病变的存在
- 金属或电子植入物和其他 MRI 特定排除标准
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:35 小儿阻塞性睡眠呼吸暂停
研究人员还将确定针对小儿 OSA 6 个月呼吸状况的标准外科手术“腺扁桃体切除术”后,脑组织变化、CBF 减少以及对认知挑战的神经反应改变是否逆转,以及认知和情绪体征是否有所改善。
|
腺样体扁桃体切除术是小儿 OSA 治疗的标准外科手术,包括切除肥大的扁桃体和腺样体。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
基线和腺样体扁桃体切除术后的脑组织变化。
大体时间:6个月
|
研究人员将检查小儿阻塞性睡眠呼吸暂停受试者在腺样体扁桃体切除术后脑组织变化是否逆转。
研究人员将使用基于扩散张量成像的平均扩散率和基于扩散峰度成像的平均峰度测量来检查脑组织变化;这两个程序检查脑组织的完整性,平均扩散率显示减少和平均峰度表明急性组织变化的值增加,并且平均扩散率显示增加和平均峰度显示慢性组织变化的值减少。
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6个月
|
基线和腺样体扁桃体切除术后区域脑脑血流量的变化。
大体时间:6个月
|
使用动脉自旋标记磁共振成像,研究人员将评估儿科受试者在标准阻塞性睡眠呼吸暂停手术后局部脑血流是否改善。
脑血流量值随着低灌注而降低,随着高灌注而增加。
|
6个月
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腺样体扁桃体切除术前后的神经反应变化。
大体时间:6个月
|
使用功能性磁共振成像,研究人员将检查与儿科阻塞性睡眠呼吸暂停受试者的基线相比,腺样体切除术后大脑认知控制部位对算术认知挑战的神经反应是否会有所改善。
|
6个月
|
腺样体扁桃体切除术后的认知症状检查。
大体时间:6个月
|
研究人员将检查小儿阻塞性睡眠呼吸暂停受试者腺样体扁桃体切除术后认知症状的变化。
研究人员将使用 Differential Ability Scale II 进行认知评估。
差异能力量表 II 得分范围为 30-170,数值降低表明认知受损(一般概念能力得分 <90,异常;一般概念能力得分 >90-170,正常)。
|
6个月
|
小儿阻塞性睡眠呼吸暂停患者腺样体扁桃体切除术后的认知评估。
大体时间:6个月
|
研究人员将评估小儿阻塞性睡眠呼吸暂停受试者腺样体扁桃体切除术后的认知变化。
研究人员将使用 NEuroPSYchological Assessment II 进行认知检查。
NEuroPSYchological Assessment II 评分会随着认知受损而降低(评分 <8,异常;评分 8-19,正常)。
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6个月
|
腺样体扁桃体切除手术后的情绪变化。
大体时间:6个月
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研究人员将使用儿童行为检查表检查小儿阻塞性睡眠呼吸暂停受试者腺样体扁桃体切除术后的情绪变化。
与对照儿童相比,儿童阻塞性睡眠呼吸暂停的情绪症状儿童行为检查表得分更高(t 得分,65-69 临界值;>70 临床)。
|
6个月
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年5月14日
初级完成 (估计的)
2024年4月30日
研究完成 (估计的)
2024年7月31日
研究注册日期
首次提交
2022年4月11日
首先提交符合 QC 标准的
2022年5月5日
首次发布 (实际的)
2022年5月10日
研究记录更新
最后更新发布 (估计的)
2023年7月24日
上次提交的符合 QC 标准的更新
2023年7月20日
最后验证
2023年7月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
一旦研究结果发表,MRI 数据(没有个人标识符)将被放置在一个只读的匿名文件传输协议 (ftp) 服务器上,可以通过电子邮件 ID 以传统方式访问。
请求访问数据的调查人员将通过学术电子邮件地址向我们发送电子邮件,并提供他们提议的项目/目的的描述。
只要项目不需要个人身份信息,就可以向提出请求的调查员提供数据访问权限。
这样的存储代表了容量的巨大承诺,因为数据预计需要数 TB。
来自同一人群的 MRI 数据(6 个月的术前和术后)、认知和情绪评分以及 OSA 疾病严重程度将对该领域特别有价值,因为儿童 OSA 患者很少有这些数据。
IPD 共享时间框架
学习完成后一年。
IPD 共享支持信息类型
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.