简体中文|English
Trial search Nation, Province(City) Code of disease Primary sponsor(s) Secondary sponsor(s) Funding source Recruiting status Register status Measure Ethical committee Study type

Research into the Development and Clinical Translation of a Wearable System for Targeted Regulation of the Rapid Eye Movement (REM) Stage in Adolescents with Psychological Trauma

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注册号：

Registration number：

ChiCTR2600126952 

最近更新日期：

Date of Last Refreshed on：

2026-06-21 10:47:58 

注册时间：

Date of Registration：

2026-06-21 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

青少年心理创伤的快速眼动期靶向调控可穿戴系统的研发与临床转化研究

Public title：

Research into the Development and Clinical Translation of a Wearable System for Targeted Regulation of the Rapid Eye Movement (REM) Stage in Adolescents with Psychological Trauma

注册题目简写：

English Acronym：

研究课题的正式科学名称：

青少年心理创伤的快速眼动期靶向调控可穿戴系统的研发与临床转化研究

Scientific title：

Research into the Development and Clinical Translation of a Wearable System for Targeted Regulation of the Rapid Eye Movement (REM) Stage in Adolescents with Psychological Trauma

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

徐鑫鹏 

研究负责人：

李晓虹 

Applicant：

Xu XinPeng  

Study leader：

Li Xiaohong  

申请注册联系人电话：

Applicant telephone：

+86 136 6137 9513

研究负责人电话：

Study leader's telephone：

+86 158 1040 2944

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

dr_xpxu@163.com

研究负责人电子邮件：

Study leader's E-mail：

lxhshy2002@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

北京市昌平区回龙观南店路7号

研究负责人通讯地址：

北京市昌平区回龙观南店路7号

Applicant address：

7 Nandian Road, Huilongguan, Changping District, Beijing, China

Study leader's address：

7 Nandian Road, Huilongguan, Changping District, Beijing, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

首都医科大学附属北京回龙观医院

Applicant's institution：

Beijing Huilongguan Hospital, Capital Medical University

研究负责人所在单位：

首都医科大学附属北京回龙观医院

Affiliation of the Leader：

Beijing Huilongguan Hospital, Capital Medical University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2026-48-科

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

首都医科大学附属北京回龙观医院伦理委员会

Name of the ethic committee：

The Ethic Committee of Beijing Huilongguan Hospital, Capital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2026-04-14 00:00:00

伦理委员会联系人：

孙延囡

Contact Name of the ethic committee：

Yannan Sun

伦理委员会联系地址：

北京市昌平区回龙观南店路7号

Contact Address of the ethic committee：

7 Nandian Road, Huilongguan, Changping District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 8302 4461

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

首都医科大学附属北京回龙观医院

Primary sponsor：

Beijing Huilongguan Hospital, Capital Medical University

研究实施负责（组长）单位地址：

北京市昌平区回龙观南店路7号

Primary sponsor's address：

7 Nandian Road, Huilongguan, Changping District, Beijing, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京市

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

首都医科大学附属北京回龙观医院

具体地址：

北京市昌平区回龙观南店路7号

Institution
hospital：

Beijing Huilongguan Hospital, Capital Medical University

Address：

7 Nandian Road, Huilongguan, Changping District, Beijing, China

经费或物资来源：

首都高端领军人才聚集培养工程科技创新领军人才

Source(s) of funding：

Capital City High-End Leading Talent Cultivation Programme: Leading Talents in Scientific and Technological Innovation

Target disease：

Mental disorders associated with psychological trauma

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究旨在通过两阶段工作，研发并验证一种针对青少年心理创伤的创新干预方法并推动其临床转化：首先，通过横断面研究，明确伴有心理创伤的青少年精神障碍患者是否存在特异的睡眠特征异常及其神经机制；进而，通过随机对照试验，评估EMDR联合快速眼动睡眠期TMR这一联合方案的有效性与作用机制，为研发基于睡眠脑电监测的可穿戴调控系统、实现临床转化提供理论与实证基础。  

Objectives of Study：

This study aims to develop and validate an innovative intervention for psychological trauma in adolescents and to facilitate its clinical translation through a two-phase approach: Firstly, through a cross-sectional study, we will determine whether adolescents with mental disorders accompanied by psychological trauma exhibit specific sleep abnormalities and their underlying neural mechanisms; subsequently, through a randomised controlled trial, we will evaluate the efficacy and mechanism of action of a combined treatment protocol involving EMDR and TMR during REM sleep, thereby providing the theoretical and empirical foundation for the development of a wearable regulation system based on sleep EEG monitoring and its clinical translation.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. 患者纳入标准： (1) 依据ICD-10诊断为创伤后应激障碍、抑郁障碍、焦虑障碍、双相障碍或其他精神障碍的患者； (2) 年龄12-18岁； (3) CTQ 量表筛查阳性，即分量表情感虐待≥13 分或身体虐待≥10 分或性虐待≥8 分或情感忽视≥15 分或身体忽视≥10分； (4) 患者同意参加此项目，并签署知情同意书。 2. 健康对照组纳入标准： (1) 不满足ICD-10中任何精神疾病的诊断标准； (2) 与患者组年龄、受教育程度匹配； (3) 年龄12-18岁； (4) 同意参加此项目，并签署知情同意书。

Inclusion criteria

1. Inclusion criteria for patients group: (1) Patients diagnosed with post-traumatic stress disorder, depressive disorder, anxiety disorder, bipolar disorder or other mental disorders according to ICD-10; (2) Aged 12–18 years; (3) A positive screening result on the CTQ scale, i.e. a score of ≥13 on the emotional abuse subscale, or >=10 on the physical abuse subscale, or ≥8 on the sexual abuse subscale, or ≥15 on the emotional neglect subscale, or >= 10 on the physical neglect subscale; (4) The patient agrees to participate in this study and has signed an informed consent form. 2. Inclusion criteria for healthy control group: (1) did not meet the diagnostic criteria for any psychiatric disorder according to ICD‑10; (2) were matched to the patient group for age and educational level; (3) were aged 12–18 years; (4) agreed to participate in the study and provided written informed consent.

排除标准：

1. 患者排除标准： (1) 存在精神分裂症、酒精使用障碍或物质使用障碍的患者； (2) 在研究开始前一周至研究期结束期间使用苯二氮卓类药物或其他睡眠药物； (3) 在试验期间饮酒、喝咖啡； (4) 存在自杀、自伤意念； (5) 存在神经系统疾病病史或近期存在严重头部外伤伴意识丧失的病史； (6) 不规则的睡眠/觉醒节律(例如，夜班、时差)及梦游； (7) 近三个月参加或正在参加重复经颅磁刺激治疗、无抽搐电休克治疗、认知行为治疗等其他非药物治疗。 2. 健康对照组排除标准： (1) 脑器质性疾病或病史； (2) 严重的或不稳定的心、肝、肾、内分泌、血液等疾病； (3) 任何精神障碍患病；或癫痫发作风险； (4) 曾经有过自杀尝试、自伤意念等； (5) 物质依赖者； (6) 不规则的睡眠/觉醒节律(例如，夜班、时差)及梦游； (7) 体内有金属、电子设备植入或其他不适宜做磁共振者。

Exclusion criteria：

1. Exclusion criteria for patients group: (1) Patients with schizophrenia, alcohol use disorder or substance use disorder; (2) Use of benzodiazepines or other sleep-inducing medication during the period from one week prior to the start of the study until the end of the study period; (3) Consumption of alcohol or coffee during the study period; (4) Presence of suicidal or self-harming thoughts; (5) History of neurological disorders or recent history of severe head trauma with loss of consciousness; (6) Irregular sleep-wake patterns (e.g., night shifts, jet lag) and sleepwalking; (7) Participation in, or current participation in, other non-pharmacological treatments such as repetitive transcranial magnetic stimulation, non-convulsive electroconvulsive therapy or cognitive behavioural therapy within the past three months. 2. Exclusion criteria for the healthy control group: (1) Organic brain disease; (2) Severe systemic disorders; (3) Psychiatric illness or seizure risk; (4) History of suicidality or self‑harm; (5) Substance dependence; (6) Circadian rhythm disruption or sleepwalking; (7) Presence of metal implants, electronic devices, or any other contraindications to magnetic resonance imaging (MRI).

研究实施时间：

Study execute time：

从 From 2026-02-01 00:00:00至 To 2028-02-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-07-01 00:00:00 至 To 2027-07-01 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

28

Group：

Experimental group

Sample size：

干预措施：

EMDR联合REM睡眠期TMR干预

干预措施代码：

Intervention：

Eye Movement Desensitization and Reprocessing (EMDR) combined with targeted memory reactivation (TMR) during rapid eye movement sleep period.

Intervention code：

组别：

对照组

样本量：

28

Group：

Control group

Sample size：

干预措施：

EMDR + REM期伪刺激

干预措施代码：

Intervention：

EMDR + REM-phase pseudo-stimulation

Intervention code：

组别：

健康对照组

样本量：

56

Group：

Healthy control group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

NONE

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京市 

市(区县)：

 昌平区 

Country：

China 

Province：

Beijing  

City：

Changping 

单位(医院)：

首都医科大学附属北京回龙观医院 

单位级别：

三甲 

Institution
hospital：

Beijing Huilongguan Hospital, Capital Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

客观睡眠结构参数

指标类型：

主要指标

Outcome：

Objective sleep structure parameters

Type：

Primary indicator

测量时间点：

测量方法：

基于PSG记录的客观睡眠结构参数

Measure time point of outcome：

Measure method：

Objective sleep architecture parameters derived from polysomnography (PSG) recordings.

指标中文名：

关键大脑网络内部及其间的功能连接强度

指标类型：

次要指标

Outcome：

The strength of functional connectivity within and between key brain networks

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

主观睡眠指标

指标类型：

次要指标

Outcome：

Subjective sleep measures

Type：

Secondary indicator

测量时间点：

测量方法：

匹兹堡睡眠质量指数总分及其各成分得分、Epworth嗜睡量表总分，以及噩梦困扰问卷（中文版）总分

Measure time point of outcome：

Measure method：

The total score of the Pittsburgh Sleep Quality Index (PSQI) and its component scores, the total score of the Epworth Sleepiness Scale (ESS), and the total score of the Chinese version of the Nightmare Distress Questionnaire (NDQ).

指标中文名：

静息态脑电图频谱特征

指标类型：

次要指标

Outcome：

Spectral characteristics of resting-state electroencephalograms

Type：

Secondary indicator

测量时间点：

测量方法：

各频段（如θ、α、β频段）的功率谱密度，以及反映情绪处理侧化机制的额叶α波不对称性等指标

Measure time point of outcome：

Measure method：

Power spectral density (PSD) in various frequency bands (e.g. θ, α, β), and frontal alpha asymmetry as an indicator of lateralized emotional processing.

指标中文名：

任务态脑电图指标

指标类型：

次要指标

Outcome：

EEG parameters during task performance

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

创伤症状

指标类型：

主要指标

Outcome：

Symptoms of trauma

Type：

Primary indicator

测量时间点：

测量方法：

CAPS-5 & PTSD检查表-民用版

Measure time point of outcome：

Measure method：

Clinician-Administered PTSD Scale for DSM-5, PTSD Checklist for DSM-5 – Civilian Version

指标中文名：

皮肤电反应

指标类型：

次要指标

Outcome：

skin conductance response

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

睡眠日记

指标类型：

次要指标

Outcome：

Sleep Diary

Type：

Secondary indicator

测量时间点：

测量方法：

分析干预后一周内梦境内容、频率及主观睡眠质量的变化

Measure time point of outcome：

Measure method：

Changes in dream content, dream frequency, and subjective sleep quality within one week after the intervention

指标中文名：

PSG客观指标

指标类型：

次要指标

Outcome：

PSG's objective indicators

Type：

Secondary indicator

测量时间点：

测量方法：

分析干预当晚REM睡眠的潜伏期、持续时间、比例及微观特征，并与对照组进行比较。

Measure time point of outcome：

Measure method：

Changes in dream content, dream frequency, and subjective sleep quality within 1 week after the intervention

指标中文名：

静息态及任务态脑电

指标类型：

次要指标

Outcome：

Resting-state and task-based EEG

Type：

Secondary indicator

测量时间点：

测量方法：

分析干预前后特定频段振荡功率、事件相关电位成分的变化。

Measure time point of outcome：

Measure method：

Pre- vs. post-intervention changes in frequency band oscillatory power and ERP components.

指标中文名：

脑网络连接

指标类型：

次要指标

Outcome：

Brain connectivity

Type：

Secondary indicator

测量时间点：

测量方法：

通过功能磁共振成像，比较干预前后默认网络、凸显网络、中央执行网络及恐惧相关回路的功能连接变化

Measure time point of outcome：

Measure method：

Functional magnetic resonance imaging (fMRI) was used to compare changes in functional connectivity within the default mode network (DMN), salience network (SN), central executive network (CEN), and fear-related circuits before and after the intervention.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

none

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 12 岁 years
最大 Max age 18 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本研究第一阶段不涉及随机化和盲法。 本研究第二阶段中，入组患者进行统一的基线测量后，其匿名化被试编号按照基于Matlab生成的随机数字表被分配在EMDR-TMR组和单一EMDR组中(比例为1:1)。随机分组数据一式两份进行封存，并交由项目外部门保存。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The first phase of this study did not involve randomisation or blinding. In the second phase of this study, following standardised baseline assessments of enrolled patients, their anonymised participant codes were assigned to the EMDR-TMR group and the single EMDR group (in a 1:1 ratio) using a random number table generated in Matlab. Two copies of the randomisation data were sealed and entrusted to a department external to the project for safekeeping.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

抽签由负责入组的科研人员进行，基础量表测评人员、患者及患者家属不知晓入组和治疗方式。完成样本采集后，预处理所有数据，并将个人信息匿名化处理。睡眠过程中患者均佩戴声音刺激的耳机，但工作人员在执行干预前后均不知是否会播放刺激声音。

Blinding：

The draw was conducted by the researcher responsible for recruitment; the personnel administering the baseline assessments, the patients, and their families were unaware of the group allocation or treatment modality. Following the completion of data collection, all data were pre-processed and personal information was anonymised. During sleep, patients wore headphones delivering auditory stimuli; however, staff were unaware whether the stimuli would be played before or after the intervention.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

无

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

NONE

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

针对本研究制定针对性的数据管理计划，在获得主要研究者审核批准后依据数据管理计划规范开展数据管理工作，包括数据管理人员的授权、依据研究方案原始记录建立纸质版数据库、数据管理、数据资料处理和存档等。 （1）原始记录表的设计：根据方案要求设计纸质版CRF进行数据采集，形成相应的数据采集指南，经主要研究者审查并批准后定稿。 （2）数据核查：数据管理员依据研究方案及研究病历撰写数据管理计划书，经主要研究者审核批准后定稿使用，依据数据管理计划书对数据进行数据管理。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

A tailored data management plan shall be drawn up for this study. Following review and approval by the principal investigator, data management activities shall be carried out in accordance with the provisions of the data management plan, including the authorisation of data management personnel, the creation of a paper-based database based on the source documents of the study protocol, data management, data processing and archiving. (1) Design of source data forms: Paper-based CRFs shall be designed in accordance with the protocol requirements for data collection, and corresponding data collection guidelines shall be drawn up. These shall be finalised following review and approval by the principal investigator. (2) Data verification: The data manager shall draft a data management plan based on the study protocol and patient records; this shall be finalised and implemented following review and approval by the principal investigator, and data management shall be carried out in accordance with the data management plan.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-06-21 10:34:56
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