ChiCTR2500115079 版本V1.0 版本创建时间2025/12/22 15:34:36 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：

ChiCTR2500115079 

最近更新日期：

Date of Last Refreshed on：

2025-12-22 15:34:29 

注册时间：

Date of Registration：

2025-12-22 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

非光与光授时因子对生理和行为节律的比较生物学研究

Public title：

How Light and Other Daily Cues Influence Biological Rhythms in Humans

注册题目简写：

English Acronym：

研究课题的正式科学名称：

非光与光授时因子对生理和行为节律的比较生物学研究

Scientific title：

Comparative Biological Study of Non-Photic and Photonic Zeitgebers in Regulating Physiological and Behavioral Rhythms

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：

沈嘉伟 

研究负责人：

顾永昊 

Applicant：

Jiawei Shen 

Study leader：

Yonghao Gu 

申请注册联系人电话：

Applicant telephone：

+86 187 5654 6158

研究负责人电话：

Study leader's telephone：

+86 135 0560 8975

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：

sjiawei@ustc.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

jianjunm@ustc.edu.cn

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：

安徽省合肥市庐江路17号

研究负责人通讯地址：

安徽省合肥市庐江路17号

Applicant address：

No. 17, Lujiang Road, Hefei City, Anhui Province

Study leader's address：

No. 17, Lujiang Road, Hefei City, Anhui Province

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：

中国科学技术大学附属第一医院

Applicant's institution：

The First Affiliated Hospital, University of Science and Technology of China

研究负责人所在单位：

中国科学技术大学附属第一医院

Affiliation of the Leader：

The First Affiliated Hospital, University of Science and Technology of China

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：

2025KY伦审第401号

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：

中国科学技术大学附属第一医院医学研究伦理委员会

Name of the ethic committee：

Medical Research Ethics Committee of the First Affiliated Hospital, University of Science and Technology of China

伦理委员会批准日期：

Date of approved by ethic committee：

2025-08-31 00:00:00

伦理委员会联系人：

沈爱宗

Contact Name of the ethic committee：

Aizong Shen

伦理委员会联系地址：

安徽省合肥市庐江路17号

Contact Address of the ethic committee：

No. 17, Lujiang Road, Hefei City, Anhui Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 551 6228 2931

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：

中国科学技术大学附属第一医院

Primary sponsor：

The First Affiliated Hospital of the University of Science and Technology of China

研究实施负责（组长）单位地址：

安徽省合肥市庐江路17号

Primary sponsor's address：

No. 17, Lujiang Road, Hefei City, Anhui 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)：

安徽

市(区县)：

Country：

China

Province：

Anhui

City：

单位(医院)：

中国科学技术大学附属第一医院

具体地址：

安徽省合肥市庐江路17号

Institution
hospital：

The First Affiliated Hospital, University of Science and Technology of China

Address：

No. 17, Lujiang Road, Hefei City, Anhui Province

经费或物资来源：

国家重点研发计划2024YFA1803200

Source(s) of funding：

National Key Research and Development Program of China (2024YFA1803200)

Target disease：

circadian rhythm

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：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

光与非光授时因子的整合依赖既有共享又有差异的分子途径，这些途径共同调节昼夜节律。整合机制受损引发节律紊乱及相关生理功能异常，失明哺乳动物因缺乏光输入，依赖保守的非光授时机制维持节律。通过与正常人对比，探索光授时弱化下非光因子通路的增强机制，为解析光与非光因子整合奠定基础。本课题以解析光与非光因子协同调控节律的神经环路为核心，重点揭示非光因子在生物钟失调中的补偿作用。研究将基于健康人和视力障碍患者，比较光与非光因子对代谢、睡眠和运动节律的差异性调控，利用可穿戴设备监测非光因子干预对人体生理行为的影响  

Objectives of Study：

The integration of light and non-light zeitgeber factors relies on both shared and distinct molecular pathways, which together regulate circadian rhythms. Impairment of the integration mechanism leads to rhythm disorders and related physiological dysfunctions. In blind mammals, lacking light input, rhythms are maintained through conserved non-light timing mechanisms. By comparing with normal individuals, the mechanisms by which non-light factor pathways are enhanced under weakened light cues can be explored, laying the foundation for understanding the integration of light and non-light factors.This project focuses on analyzing neural circuits that coordinate the regulation of rhythmicity by both light and non-light factors, with an emphasis on revealing the compensatory role of non-light factors in circadian rhythm disorders. The study will be based on healthy individuals and patients with visual impairments, comparing the differential regulation of metabolism, sleep, and activity rhythms by light and non-light factors, and using wearable devices to monitor the effects of non-light factor interventions on human physiological behavior.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

双眼全盲组（30人）： 1.双眼球摘除术后或双眼球萎缩或双眼无光感者，>3年； 2.双眼视力检查为无光感； 3.双眼视野检测不出； 4.双眼视觉诱发电位（VEP）均无明显波形； 5.双眼瞳孔对光反射直接和间接均消失（对双眼球存在者）； 6.影像学检查证实双眼球缺如（对双眼球萎缩或摘除者）； 7. 年龄18-60岁 ； 正常对照组（30人）： 1. 双眼矫正视力均>=0.8； 2. 双眼视野和VEP均在正常范围内； 3. 既往无眼部器质性疾病史或手术史 ； 4. 年龄18-60岁.

Inclusion criteria

Totally Blind Group (30 participants): 1. Individuals who have undergone bilateral enucleation, have bilateral ocular atrophy, or have no light perception in both eyes for more than 3 years; 2. Visual acuity testing shows no light perception in both eyes; 3. Visual field testing shows no detectable field in both eyes; 4. Visual Evoked Potentials (VEP) in both eyes show no clear waveform; 5. Direct and consensual pupillary light reflexes are absent in both eyes (for those with eyes present); 6. Imaging confirms the absence of both eyes (for those with bilateral ocular atrophy or enucleation); 7. Age 18-60 years. Normal Control Group (30 participants): 1. Corrected visual acuity of both eyes >= 0.8; 2. Visual field and VEP within normal range in both eyes; 3. No history of ocular organic disease or surgery; 4. Age 18-60 years.

排除标准：

1.严重或控制不良的系统性疾病，如糖尿病、高血压等; 2.心理和睡眠节律评估不适应进行本项目的受试者; 3.神经系统病史患者.

Exclusion criteria：

1. Severe or poorly controlled systemic diseases, such as diabetes, hypertension, etc.; 2. Subjects unsuitable for this project due to psychological or sleep rhythm assessments; 3. Patients with a history of neurological disorders.

研究实施时间：

Study execute time：

从 From 2025-10-09 00:00:00至 To 2029-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-01 00:00:00 至 To 2026-12-12 00:00:00  

干预措施：

Interventions：

组别：

盲人组

样本量：

30

Group：

Blind group

Sample size：

干预措施：

第一阶段（居家观察）：受试者在正常工作与生活状态下参与，三餐由项目组统一配送。期间需佩戴多种无创监测设备，包括环境光监测勋章、体动记录仪、体温贴片、心电监测仪、便携式血压计及微创动态血糖记录仪。研究对日常生活无影响。在指定日期需配合采集唾液样本，自19:00起每小时一次，共5次，样本需冷冻保存，由专人上门收取。 第二阶段（住院观察）：受试者入住中国科学技术大学附属第一医院GCP病房7天。监测设备与唾液采集方式与第一阶段一致，入院首日与第七天将进行常规体检与抽血。住院期间，禁止使用显示时间信息的设备（如手表、手机等），房间照明将根据第一阶段的用灯习惯自动控制。受试者可自由安排活动，如收听无时间信息的音频、阅读盲文、手工或运动。可通过座机或语音与家人朋友联系，但交流中不得涉及时间信息。三餐与饮水按个人需要随时提供。 第三阶段（恢复观察）：为期7天，受试者返回正常生活与工作状态，三餐继续由项目组提供并配送。

干预措施代码：

Intervention：

Phase I: At-Home Observation Participants will take part while maintaining their normal work and daily routines, with all meals provided by the study team. During this phase, they will wear multiple non-invasive monitoring devices, including an environmental light sensor, actigraphy device, skin temperature patch, ECG monitor, portable blood pressure meter, and a minimally invasive continuous glucose monitor. The study procedures will not interfere with daily activities. On designated days, participants will collect saliva samples once per hour from 19:00 for a total of five samples, which must be stored frozen and will be collected by designated personnel. Phase II: Inpatient Observation Participants will be admitted to the GCP ward of the First Affiliated Hospital of the University of Science and Technology of China for seven days. Monitoring devices and saliva collection procedures will be identical to those in Phase I. Routine physical examinations and blood sampling will be performed on Day 1 and Day 7 of hospitalization. During the inpatient stay, participants are prohibited from using any device that displays time information (e.g., watches, mobile phones). Room lighting will be automatically controlled based on the participant’s lighting habits recorded in Phase I. Participants may freely engage in activities such as listening to audio programs without time cues, reading Braille texts, handicrafts, or exercising. Communication with family and friends is permitted via landline telephone or voice calls, but conversations must not include any information related to time. Meals and drinking water will be provided on demand. Phase III: Recovery Observation This 7-day phase takes place after discharge. Participants will return to their normal work and daily life, with all meals continuing to be prepared and delivered by the study team.

Intervention code：

组别：

对照组

样本量：

30

Group：

Control group

Sample size：

干预措施：

本研究共分三个阶段，每阶段为期5天4晚，均在中国科学技术大学附属第一医院（安徽省立医院）GCP病房进行。受试者全程佩戴项目组提供的环境光监测勋章及体动记录仪（均为无创设备）。 第一阶段：第1天上午入住病房并适应环境。第2至4天白天接受不同光照任务：第2天和第4天早餐前约1小时处于>1000 lux照度，早餐后至19:00维持约50 lux环境；第3天全程处于>1000 lux照度。第2至4晚19:00至次日1:00，每30分钟采集1次唾液（约2 mL），共36份样本。日间可进行电脑办公、听音频、阅读、桌游等活动。项目组提供三餐（低褪黑素食物）及不含咖啡因、酒精的饮品，工作人员全程陪护并监测安全。 第二阶段：流程与第一阶段相同，但第3天17:00–19:00增加跑步机运动任务：热身10分钟（VO2max 25%）、中高强度运动40分钟（VO?max 75%）、恢复10分钟（VO2max 25%），个体VO2max在入组时测定。其余光照、样本采集、饮食与陪护安排相同。 第三阶段：流程与第一阶段一致，仅在第3天增加1小时跑步机运动（强度同第二阶段）。其余观察、采样及生活安排均相同。

干预措施代码：

Intervention：

Phase I: This study consists of three phases, each lasting 5 days and 4 nights, all conducted in the GCP ward of the First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital). Participants continuously wear a light-monitoring badge and an actigraphy device (both non-invasive). In Phase I, participants are admitted on the morning of Day 1 for acclimation. On Days 2–4, daytime light-exposure tasks are performed: on Days 2 and 4, participants receive >1000 lux light for approximately 1 hour before breakfast and then remain in ~50 lux ambient light until 19:00; on Day 3, they are exposed to >1000 lux throughout the entire day. From 19:00 to 01:00 on Nights 2–4, saliva samples (~2 mL each) are collected every 30 minutes for a total of 36 samples. During the day, participants may engage in computer work, listening to audio, reading, or board games. Meals (low-melatonin foods) and caffeine-free, alcohol-free beverages are provided, and staff remain present to ensure safety. Phase II: Phase II follows the same procedures as Phase I, with the addition of a treadmill exercise task on Day 3 from 17:00 to 19:00. The exercise protocol consists of a 10-minute warm-up at 25% VO2max, 40 minutes of moderate-to-high-intensity exercise at 75% VO?max, and a 10-minute cool-down at 25% VO2max. Individual VO2max values are determined at enrollment. All other aspects—including light-exposure schedules, saliva collection, meals, beverages, daily activities, and staff supervision—remain consistent with Phase I. Phase III: Phase III is identical to Phase I except for the inclusion of a 1-hour treadmill exercise session on Day 3, using the same exercise intensity parameters as in Phase II. All other observation procedures, sampling schedules, safety monitoring, dietary provisions, and daily living arrangements remain unchanged from the previous phases.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 安徽 

市(区县)：

 合肥 

Country：

China 

Province：

Anhui 

City：

Hefei 

单位(医院)：

中国科学技术大学附属第一医院 

单位级别：

三甲 

Institution
hospital：

The First Affiliated Hospital of the University of Science and Technology of China

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

唾液褪黑素节律

指标类型：

主要指标

Outcome：

salivary melatonin circadian rhythm

Type：

Primary indicator

测量时间点：

每晚19:00到次日1:00，每间隔30分钟才一次唾液

测量方法：

Measure time point of outcome：

Saliva samples will be collected every 30 minutes from 19:00 to 01:00 the following day.

Measure method：

指标中文名：

睡眠-觉醒节律

指标类型：

次要指标

Outcome：

sleep-wake circadian rhythm

Type：

Secondary indicator

测量时间点：

全天24小时检测

测量方法：

Measure time point of outcome：

Continuous 24-hour monitoring was conducted

Measure method：

指标中文名：

血糖节律

指标类型：

次要指标

Outcome：

blood glucose circadian rhythm

Type：

Secondary indicator

测量时间点：

全天24小时检测

测量方法：

Measure time point of outcome：

Continuous 24-hour monitoring was conducted

Measure method：

指标中文名：

体温节律

指标类型：

主要指标

Outcome：

body temperature circadian rhythm

Type：

Primary indicator

测量时间点：

全天24小时检测

测量方法：

Measure time point of outcome：

Continuous 24-hour monitoring was conducted

Measure method：

指标中文名：

血液代谢组信息

指标类型：

主要指标

Outcome：

Blood metabolomics data

Type：

Primary indicator

测量时间点：

实验期间部分天数采集血液，采集血液当天为1小时一次，每次1-2mL

测量方法：

Measure time point of outcome：

During the experimental period, blood samples were collected on selected days. On blood collection days, samples were obtained once every hour, with 1–2 mL collected per time point.

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

唾液

组织：

Sample Name：

Saliva

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

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 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）：

无

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

None

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：

无

Blinding：

None

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：

CRF

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

CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-12-22 15:34:29