ChiCTR2600123430 版本V1.0 版本创建时间2026/04/27 00:46:30 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600123430 

最近更新日期：

Date of Last Refreshed on：

 2026-04-27 00:46:23 

注册时间：

Date of Registration：

 2026-04-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

40Hz双耳节拍听觉干预对老年髋部手术患者术后谵妄的影响及围术期噪音相关性分析

Public title：

Effect of 40-Hz Binaural Beat Auditory Intervention on Postoperative Delirium in Elderly Patients Undergoing Hip Surgery: A Randomized Clinical Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

40Hz双耳节拍听觉干预对老年髋部手术患者术后谵妄的影响及围术期噪音相关性分析

Scientific title：

Effect of 40-Hz Binaural Beat Auditory Intervention on Postoperative Delirium and Perioperative Noise Correlation Analysis in Elderly Patients Undergoing Hip Surgery

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：

孙晓佳 

研究负责人：

孙晓佳 

Applicant：

Sun Xiaojia 

Study leader：

Sun Xiaojia 

申请注册联系人电话：

Applicant telephone：

 +86 153 6931 2965

研究负责人电话：

Study leader's
telephone：

+86 153 6931 2965

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：

 1581571243@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 1581571243@qq.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：

河北省张家口桥西区长青路12号

研究负责人通讯地址：

河北省张家口桥西区长青路12号

Applicant address：

No. 12 Changqing Road, Qiaoxi District, Zhangjiakou City, Hebei Province

Study leader's address：

This study will be conducted in strict accordance with clinical trial principles and ethical requirements. We aim to ensure the safety, rights and interests of all participants, and to obtain reliable, objective and high-quality clinical evidence for the prevention and treatment of postoperative delirium

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：

河北北方学院附属第一医院

Applicant's institution：

The First Affiliated Hospital of Hebei North University

研究负责人所在单位：

河北北方学院附属第一医院

Affiliation of the Leader：

The First Affiliated Hospital of Hebei North University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 L2026036

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：

河北北方学院附属第一医院伦理委员会

Name of the ethic committee：

Ethics Committee of The First Affiliated Hospital of Hebei North University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-03-28 00:00:00

伦理委员会联系人：

黄晓梦

Contact Name of the ethic committee：

Ethics Committee of The First Affiliated Hospital of Hebei North University

伦理委员会联系地址：

河北省张家口市桥西区长青路12号

Contact Address of the ethic committee：

No. 12 Changqing Road, Qiaoxi District, Zhangjiakou City, Hebei Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 156 1230 6910

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：

河北北方学院附属第一医院

Primary sponsor：

The First Affiliated Hospital of Hebei North University

研究实施负责（组长）单位地址：

河北省张家口市桥西区长青路12号

Primary sponsor's address：

No. 12 Changqing Road, Qiaoxi District, Zhangjiakou City, Hebei Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

河北

市(区县)：

张家口市

Country：

China

Province：

Hebei

City：

Zhangjiakou

单位(医院)：

河北北方学院附属第一医院

具体地址：

河北省张家口市桥西区长青路12号

Institution
hospital：

The First Affiliated Hospital of Hebei North University

Address：

No. 12 Changqing Road, Qiaoxi District, Zhangjiakou City, Hebei Province

经费或物资来源：

自费

Source(s) of funding：

Self-funded

研究疾病：

术后谵妄  

Target disease：

Postoperative delirium

研究疾病代码：

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：

主要目的：明确自术后麻醉恢复室（PACU）至术后第3天给予标准化40Hz双耳节拍听觉干预，能否降低老年全麻髋部手术患者术后谵妄（POD）的发生率。 次要目的：1.?基于对照组数据分析围术期高噪音暴露与老年髋部手术患者术后谵妄的相关性，探索围术期噪音暴露是否为POD的独立危险因素； 2.?评估40Hz双耳节拍听觉干预对老年髋部手术患者术后炎症因子（IL-1β、IL-6）、神经丝轻链蛋白（NFL）及睡眠质量的改善作用； 3.?观察40Hz双耳节拍听觉干预对患者术后苏醒时间、住院天数及围术期不良事件的影响。  

Objectives of Study：

Primary Objective To determine whether standardized 40Hz binaural beat auditory intervention from post-anesthesia care unit (PACU) admission up to postoperative day 3 can reduce the incidence of postoperative delirium (POD) in elderly patients undergoing general anesthesia for hip surgery. Secondary Objectives To analyze the correlation between perioperative high noise exposure and postoperative delirium in elderly hip surgery patients based on control group data, and to explore whether perioperative noise exposure is an independent risk factor for POD. To evaluate the improving effects of 40Hz binaural beat auditory intervention on postoperative inflammatory factors (IL-1β, IL-6), neurofilament light chain (NFL) levels, and sleep quality in elderly hip surgery patients. To observe the effects of 40Hz binaural beat auditory intervention on postoperative emergence time, length of hospital stay, and perioperative adverse events

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.?年龄≥65岁，性别不限； 2.?拟行全麻下择期髋部手术（包括股骨颈骨折置换术、股骨粗隆间骨折内固定术等）； 3.?美国麻醉医师协会（ASA）分级Ⅱ~Ⅳ级； 4.?术前简易智力状态检查（MMSE）评分≥24分，无确诊痴呆及严重认知功能障碍； 5.?无重度听力障碍、鼓膜穿孔、中耳炎、听觉过敏，可配合佩戴蓝牙耳机完成干预； 6.?患者或其法定代理人充分理解研究内容，自愿签署书面知情同意书； 7.?预计术后可完成至少72小时的观察及评估，无术后即刻转ICU或长期机械通气可能。

Inclusion criteria

1. Aged >= 65 years, regardless of gender; 2. Scheduled for elective hip surgery under general anesthesia (including femoral neck fracture replacement, intertrochanteric fracture internal fixation, etc.); 3. American Society of Anesthesiologists (ASA) physical status classification II–IV; 4. Preoperative Mini-Mental State Examination (MMSE) score >= 24, with no confirmed dementia or severe cognitive impairment; 5. No severe hearing impairment, tympanic membrane perforation, otitis media, or hyperacusis, and able to cooperate with intervention using Bluetooth earphones; 6. The patient or legal representative fully understands the study protocol and voluntarily provides written informed consent; 7. Expected to complete at least 72 hours of postoperative observation and assessment, with no likelihood of immediate postoperative ICU transfer or long-term mechanical ventilation.

排除标准：

1.?术前确诊痴呆、阿尔茨海默病、帕金森病等严重认知功能障碍，或有精神疾病史； 2.?合并中枢神经系统器质性病变（如脑梗死、脑出血、颅内肿瘤、脑积水等）； 3.?存在重度听力障碍、先天性听觉异常，或无法耐受耳机佩戴、对声音刺激过度敏感； 4.?术后即刻转入重症监护室（ICU）、需要机械通气支持时间＞24小时，无法完成干预及评估； 5.?合并严重肝肾功能不全、恶性肿瘤、严重感染、自身免疫性疾病等； 6.?近3个月内参加过其他临床研究； 7.?患者或家属拒绝参与本研究，或无法配合完成全程随访。

Exclusion criteria：

Preoperatively diagnosed with severe cognitive impairment such as dementia, Alzheimer’s disease, Parkinson’s disease, or with a history of psychiatric disorders; 2. Complicated with organic central nervous system lesions (e.g., cerebral infarction, cerebral hemorrhage, intracranial tumor, hydrocephalus, etc.); 3. Presence of severe hearing impairment, congenital auditory abnormalities, inability to tolerate wearing earphones, or hypersensitivity to acoustic stimulation; 4. Immediate postoperative transfer to intensive care unit (ICU), requirement of mechanical ventilation for more than 24 hours, and inability to complete intervention and assessment; 5. Complicated with severe hepatic or renal insufficiency, malignant tumor, severe infection, autoimmune disease, etc.; 6. Participation in other clinical studies within the past 3 months; 7. Refusal to participate in this study by the patient or family members, or inability to cooperate and complete the entire follow-up

研究实施时间：

Study execute time：

从 From 2026-05-01 00:00:00至 To 2027-04-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-05-01 00:00:00 至 To 2027-04-30 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 80

Group：

Intervention group

Sample size：

干预措施：

给予40Hz双耳节拍听觉干预，干预从患者PACU清醒可配合开始，至术后第3天24:00结束，具体规范如下： 1. 音频规范：采用固定40Hz双耳节拍音频文件，左声道440Hz、右声道480Hz，差频形成40Hz伽马振荡，无音乐、人声叠加，音频文件可溯源、统一保存； 2. 设备规范：使用统一型号智能手机、立体声蓝牙耳机；使用前关闭手机单声道、均衡器、环绕声、响度均衡等功能，将声道平衡调至居中； 3. 音量校准：采用A计权、慢响应声级计，在耳机出声口前1cm处进行音量校准，将音量控制在55~60 dB(A)，校准后固定手机音量档位，全研究过程保持一致； 4. 操作规范：患者取平卧或半卧位，协助其规范佩戴蓝牙耳机，确保耳部贴合、无明显压迫；干预过程中安排专人观察，患者若出现耳部不适、烦躁、头晕等症状，立即停止干预并记录； 5. 干预频次及时段：每日干预2次，每次30分钟，两次干预间隔>=6小时；首次干预于PACU患者清醒、意识清楚可配合后进行；病房内干预固定于每日上午09:00~09:30、夜间20:00~20:30进行。

干预措施代码：

Intervention：

40 Hz binaural beat auditory intervention will be administered starting when the patient is awake and cooperative in the PACU, until 24:00 on the 3rd postoperative day. Specific protocols are as follows: 1. Audio protocol: Fixed 40 Hz binaural beat audio files will be used, with a 440 Hz signal in the left channel and 480 Hz in the right channel, generating a 40 Hz gamma oscillation beat frequency. No background music or voice overlay will be included. All audio files will be traceable and uniformly stored. 2. Device protocol: Uniform-model smartphones and stereo Bluetooth earphones will be applied. Before use, mono mode, equalizer, surround sound, and loudness equalization functions on the smartphone will be disabled, and channel balance will be set to the center position. 3. Volume calibration: Volume calibration will be performed 1 cm in front of the earphone outlet using an A-weighted, slow-response sound level meter. Volume will be controlled at 55–60 dB(A). After calibration, the smartphone volume level will be fixed and maintained consistent throughout the study. 4. Operating protocol: The patient will be placed in a supine or semi-recumbent position, and assisted with proper fitting of Bluetooth earphones to ensure close contact with the ears without obvious compression. Dedicated personnel will monitor patients during intervention. If ear discomfort, restlessness, dizziness, or other symptoms occur, the intervention will be stopped immediately and documented. 5. Frequency and duration: Intervention will be delivered twice daily, 30 minutes per session, with an interval of at least 6 hours between sessions. The first intervention will be administered after the patient is awake and sufficiently cooperative in the PACU. Inward interventions will be scheduled daily at 09:00–09:30 and 20:00–20:30.

Intervention code：

组别：

对照组

样本量：

 80

Group：

Control group

Sample size：

干预措施：

给予空白对照，仅佩戴耳机不播放任何音频，具体要求如下： 1.?与干预组使用相同型号的智能手机及蓝牙耳机，佩戴方式、时长、频次与干预组完全一致； 2.?佩戴耳机期间不播放任何音频，无音乐、白噪音、节拍声等任何形式的听觉刺激； 3.?其余围术期护理、评估、随访流程与干预组保持一致。

干预措施代码：

Intervention：

Provide a blank control, wearing only headphones without playing any audio, with the specific requirements as follows: 1. Use the same model of smartphone and Bluetooth headphones as the intervention group, and wear them in exactly the same way, duration, and frequency as the intervention group; 2. Do not play any audio while wearing the headphones, including music, white noise, beats, or any other form of auditory stimulation; 3. Other perioperative care, assessments, and follow-up procedures should remain consistent with the intervention group.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河北 

市(区县)：

  

Country：

China

Province：

Hebei

City：

单位(医院)：

 河北北方学院附属第一医院 

单位级别：

 三甲 

Institution
hospital：

The First Affiliated Hospital of Hebei North University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

术后谵妄（POD）发生率

指标类型：

主要指标

Outcome：

Incidence of postoperative delirium (POD).

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

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 65 岁 years
最大 Max age 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）：

本研究采用年龄分层区组随机化方法。 1. 分层因素：以年龄作为分层变量，分为 A 层（65~74 岁）和 B 层（≥75 岁），每层目标样本量 80 例。 2. 序列产生：由专人利用 Excel 软件的随机数函数（RAND），为各层分别生成随机序列，并按随机数排序生成最终分组表。 3. 分配原则：每层内实施区组随机，区组长度为 4，按 1:1 比例分配至干预组或对照组

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

In this study, an age-stratified block randomization method was adopted. 1. Stratification factor: Age was used as the stratification variable, dividing subjects into Stratum A (65–74 years old) and Stratum B (≥75 years old), with a target sample size of 80 cases in each stratum. 2. Sequence generation: A dedicated researcher generated random sequences for each stratum using the RAND function in Microsoft Excel, and the final randomization table was created by sorting according to the generated random numbers. 3. Allocation principle: Block randomization was performed within each stratum with a block size of 4, and subjects were randomly assigned to the intervention group or the control group at a 1:1 ratio.

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：

由于干预为 40Hz 听觉刺激，受试者与实施干预人员无法设盲。 本研究采用评价者单盲 + 统计者盲法：结局指标（术后谵妄发生情况等）由不了解分组情况的专职人员评估；数据录入及统计分析由独立统计人员在盲态下完成，以降低偏倚。

Blinding：

Due to the nature of the intervention, double blinding was not feasible. Only outcome assessors and data analysts were blinded to group allocation to minimize measurement and analysis bias

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

否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）：

不适用，本研究不共享个体原始数据

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

Not applicable. No individual participant data (IPD) will be shared to protect participant privacy.

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：

采用纸质病例记录表（CRF）记录，数据录入 Excel 进行管理与核对

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

Data were collected using case report forms (CRF) and managed with Excel

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：

  2026-04-27 00:46:23