ChiCTR2000034006 版本V1.0 版本创建时间2024/10/11 09:32:43 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：

 ChiCTR2000034006 

最近更新日期：

Date of Last Refreshed on：

 2020-06-21 08:13:46 

注册时间：

Date of Registration：

 2020-06-21 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

A randomised controlled trial for investigation of the safety and efficacy of treating diabetic macular edema using Noctura 400 sleep mask

Public title：

A randomised controlled trial for investigation of the safety and efficacy of treating diabetic macular edema using Noctura 400 sleep mask

注册题目简写：

English Acronym：

Noctura 400 prevent DMO and DR progression

研究课题的正式科学名称：

A randomised controlled study investigating the safety and efficacy of treating diabetic macular edema using Noctura 400 sleep mask

Scientific title：

A randomised controlled study investigating the safety and efficacy of treating diabetic macular edema using Noctura 400 sleep mask

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：

Ms Jennifer Tsoi 

研究负责人：

Dr Marten Erik Brelén 

Applicant：

Ms Jennifer Tsoi 

Study leader：

Dr Marten Erik Brelén 

申请注册联系人电话：

Applicant telephone：

 +852 39435818

研究负责人电话：

Study leader's
telephone：

+852 39435806

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：

 jennifertsoi@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 marten.brelen@cuhk.edu.hk

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：

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong, China

研究负责人通讯地址：

4/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong, China

Applicant address：

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong, China

Study leader's address：

4/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong, 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：

香港中文大學眼科與視覺科學系

Applicant's institution：

Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學眼科與視覺科學系

Affiliation of the Leader：

Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong

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：

 KC/KE-19-0015/FR-3

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：

Research Ethics Committee (Kowloon Central / Kowloon East)

Name of the ethic committee：

Research Ethics Committee (Kowloon Central / Kowloon East)

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-07-30 00:00:00

伦理委员会联系人：

Ms Lyon Chan

Contact Name of the ethic committee：

Ms Lyon Chan

伦理委员会联系地址：

Room 414, Nurse Quarters, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong, China

Contact Address of the ethic committee：

Room 414, Nurse Quarters, Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 35068888

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 kckecrec@ha.org.hk

研究实施负责（组长）单位：

Research Fund Secretariat, Food and Health Bureau, The Government of HKSAR

Primary sponsor：

Research Fund Secretariat, Food and Health Bureau, The Government of HKSAR

研究实施负责（组长）单位地址：

9/F, Rumsey Street Multi-storey Carpark Building, 2 Rumsey Street, Sheung Wan, Hong Kong, China

Primary sponsor's address：

9/F, Rumsey Street Multi-storey Carpark Building, 2 Rumsey Street, Sheung Wan, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

香港中文大學眼科與視覺科學系

具体地址：

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

Institution
hospital：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

Address：

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

经费或物资来源：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong; Health and Medical Research Fund 2019 (pending)

Source(s) of funding：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong; Health and Medical Research Fund 2019 (pending)

研究疾病：

diabetic retinopathy, diabetic macular oedema  

Target disease：

diabetic retinopathy, diabetic macular oedema

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：

The aim of the evaluation is to compare and observe the efficacy of two different light emitted levels of Noctura 400 sleep mask on 300 patients with early DMO over a period of 12 months. 150 patients will be assigned randomly to each group. One group will receive the standard treatment of 2 scotopic trolands and the other will receive the lower level of light being tested which is 0.03 scotopic trolands. The results of the two groups will be compared. Results will be compared the efficacy of treatment in the two arms and their significance in the treatment of diabetic macular edema and to corelate with the level of compliance in each arm. Proposing that a low level of light will provide similar efficacy with better compliance In this study the analysis will focus on the change in key measures of diabetic macular oedema and the classification level of diabetic retinopathy. Observations will also include the need to administer standard treatments in parallel with mask use. An interim analysis will be carried out at 6 months, to ensure the study is powered correctly and to allow early publication of data if a strong efficacy signal is significant.  

Objectives of Study：

The aim of the evaluation is to compare and observe the efficacy of two different light emitted levels of Noctura 400 sleep mask on 300 patients with early DMO over a period of 12 months. 150 patients will be assigned randomly to each group. One group will receive the standard treatment of 2 scotopic trolands and the other will receive the lower level of light being tested which is 0.03 scotopic trolands. The results of the two groups will be compared. Results will be compared the efficacy of treatment in the two arms and their significance in the treatment of diabetic macular edema and to corelate with the level of compliance in each arm. Proposing that a low level of light will provide similar efficacy with better compliance In this study the analysis will focus on the change in key measures of diabetic macular oedema and the classification level of diabetic retinopathy. Observations will also include the need to administer standard treatments in parallel with mask use. An interim analysis will be carried out at 6 months, to ensure the study is powered correctly and to allow early publication of data if a strong efficacy signal is significant.

药物成份或治疗方案详述：

All 300 study participants will have a baseline (recruitment) visit in which a comprehensive briefing of the study, introduction to the mask and a demonstration on how to use will be included. Consent signatures will be collected from the participant on the same visit with a simple brief data (history) related to his/her own sleep pattern which will be used to personalize the mask for the specific sleep pattern of each participant. This visit will also include a full history taking and a baseline slit lamp examination done by an ophthalmologist with all the baseline tests and investigations (please refer below for the details of tests and investigations done at baseline and follow up visits). At the end of the visit the participant will receive his newly issued and programmed mask. First visit after issuing the mask is at month 1 and the main reason for this visit is to assess patient compliance and experience with the mask and to provide more support if needed or to clarify any concerns or queries related to the mask and study. No new mask will be issued in this visit. Visits at month 3, 6, 9, and 12 will have similar structure that include a history of compliance or any acute event related to the eye since the last visit, coaching and re-enforcing on the importance of usage and providing any help or support if needed. In these visits a group of tests will be done to measure the study outcomes (please refer below to the tests done on follow up visits). On all these visits the used mask will be taken for data collection and all participants will receive newly programmed masks. Participants in both groups must wear the sleep mask for the duration of sleep every night. The Noctura mask is designed to deliver a maximum therapeutic effect of 8 hours per night and is replaced every 12 weeks. The pod records usage data which will be downloaded at the end of month 1 and thereafter at the end of each cycle. Compliance with the treatment and checks for consistent use will be carried out and the patient will be supported and coached to achieve the highest standards of compliance. Patient will receive the standard of care after the study. The study article will not be provided to participants after the completion of study. 

Description for medicine or protocol of treatment in detail：

All 300 study participants will have a baseline (recruitment) visit in which a comprehensive briefing of the study, introduction to the mask and a demonstration on how to use will be included. Consent signatures will be collected from the participant on the same visit with a simple brief data (history) related to his/her own sleep pattern which will be used to personalize the mask for the specific sleep pattern of each participant. This visit will also include a full history taking and a baseline slit lamp examination done by an ophthalmologist with all the baseline tests and investigations (please refer below for the details of tests and investigations done at baseline and follow up visits). At the end of the visit the participant will receive his newly issued and programmed mask. First visit after issuing the mask is at month 1 and the main reason for this visit is to assess patient compliance and experience with the mask and to provide more support if needed or to clarify any concerns or queries related to the mask and study. No new mask will be issued in this visit. Visits at month 3, 6, 9, and 12 will have similar structure that include a history of compliance or any acute event related to the eye since the last visit, coaching and re-enforcing on the importance of usage and providing any help or support if needed. In these visits a group of tests will be done to measure the study outcomes (please refer below to the tests done on follow up visits). On all these visits the used mask will be taken for data collection and all participants will receive newly programmed masks. Participants in both groups must wear the sleep mask for the duration of sleep every night. The Noctura mask is designed to deliver a maximum therapeutic effect of 8 hours per night and is replaced every 12 weeks. The pod records usage data which will be downloaded at the end of month 1 and thereafter at the end of each cycle. Compliance with the treatment and checks for consistent use will be carried out and the patient will be supported and coached to achieve the highest standards of compliance. Patient will receive the standard of care after the study. The study article will not be provided to participants after the completion of study. 

纳入标准：

1. Adults (over 18 years old);
2. DM type 1 or 2;
3. Presence of diabetic macular oedema (DMO);
4. Patients who can give an HbA1c level throughout the study;
5. No previous treatments within 6months of baseline visit;
6. Any stage of non-proliferative diabetic retinopathy.

Inclusion criteria

1. Adults (over 18 years old);
2. DM type 1 or 2;
3. Presence of diabetic macular oedema (DMO);
4. Patients who can give an HbA1c level throughout the study;
5. No previous treatments within 6months of baseline visit;
6. Any stage of non-proliferative diabetic retinopathy.

排除标准：

1. Pregnant;
2. Advanced cataract or other media opacity which precludes a fundal view;
3. Any proliferative diabetic retinopathy including advanced diabetic eye disease (vitreous haemorrhage or tractional retinal detachment);
4. Unstable or poorly controlled diabetes (HbA1c levels >15);
5. Contraindications listed in the instruction of Noctura 400;
6. Unable to complete giving consent form.

Exclusion criteria：

1. Pregnant;
2. Advanced cataract or other media opacity which precludes a fundal view;
3. Any proliferative diabetic retinopathy including advanced diabetic eye disease (vitreous haemorrhage or tractional retinal detachment);
4. Unstable or poorly controlled diabetes (HbA1c levels >15);
5. Contraindications listed in the instruction of Noctura 400;
6. Unable to complete giving consent form.

研究实施时间：

Study execute time：

从 From 2020-11-01 00:00:00至 To 2023-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-11-01 00:00:00 至 To 2022-10-31 00:00:00

干预措施：

Interventions：

组别：

Group 1

样本量：

 150

Group：

Group 1

Sample size：

干预措施：

Noctura 400 (0.03 scotopic troland) sleep mask

干预措施代码：

Intervention：

Noctura 400 (0.03 scotopic troland) sleep mask

Intervention code：

组别：

Group 2

样本量：

 150

Group：

Group 2

Sample size：

干预措施：

Noctura 400 (2 scotopic trolands) sleep mask

干预措施代码：

Intervention：

Noctura 400 (2 scotopic trolands) sleep mask

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 香港眼科醫院 

单位级别：

  

Institution
hospital：

Hong Kong Eye Hospital

Level of the institution：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 威爾士親王醫院 

单位级别：

  

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

Hong Kong

Province：

Hong Kong SAR

City：

单位(医院)：

 香港理工大學 

单位级别：

 大學 

Institution
hospital：

The Hong Kong Polytechnic University

Level of the institution：

University

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 葛量洪醫院 

单位级别：

  

Institution
hospital：

Grantham Hospital

Level of the institution：

测量指标：

Outcomes：

指标中文名：

Best corrected visual acuity (BCVA)

指标类型：

主要指标

Outcome：

Best corrected visual acuity (BCVA)

Type：

Primary indicator

测量时间点：

12 months

测量方法：

ETDRS

Measure time point of outcome：

12 months

Measure method：

ETDRS

指标中文名：

Macular thickness in each zone of the ETDRS Grid

指标类型：

主要指标

Outcome：

Macular thickness in each zone of the ETDRS Grid

Type：

Primary indicator

测量时间点：

12 months

测量方法：

ETDRS

Measure time point of outcome：

12 months

Measure method：

ETDRS

指标中文名：

Maximum retinal thickness, average central subfield thickness (CST), central maximum thickness (Cmax)

指标类型：

主要指标

Outcome：

Maximum retinal thickness, average central subfield thickness (CST), central maximum thickness (Cmax)

Type：

Primary indicator

测量时间点：

12 months

测量方法：

Optical coherence topography (OCT)

Measure time point of outcome：

12 months

Measure method：

Optical coherence topography (OCT)

指标中文名：

Other anatomical changes

指标类型：

主要指标

Outcome：

Other anatomical changes

Type：

Primary indicator

测量时间点：

12 months

测量方法：

Seen clinically or documented by OCT

Measure time point of outcome：

12 months

Measure method：

Seen clinically or documented by OCT

指标中文名：

Diabetic retinopathy severity level

指标类型：

主要指标

Outcome：

Diabetic retinopathy severity level

Type：

Primary indicator

测量时间点：

12 months

测量方法：

Measurement of HbA1c level

Measure time point of outcome：

12 months

Measure method：

Measurement of HbA1c level

指标中文名：

Number of standard treatments required (Anti-VEGF injections, laser, etc.)

指标类型：

主要指标

Outcome：

Number of standard treatments required (Anti-VEGF injections, laser, etc.)

Type：

Primary indicator

测量时间点：

12 months

测量方法：

Measure time point of outcome：

12 months

Measure method：

指标中文名：

Microperimetry

指标类型：

主要指标

Outcome：

Microperimetry

Type：

Primary indicator

测量时间点：

12 months

测量方法：

Microperimetry

Measure time point of outcome：

12 months

Measure method：

Microperimetry

指标中文名：

Safety of using the Noctura 400

指标类型：

次要指标

Outcome：

Safety of using the Noctura 400

Type：

Secondary indicator

测量时间点：

12 months

测量方法：

Number of reported AE or SAE

Measure time point of outcome：

12 months

Measure method：

Number of reported AE or SAE

采集人体标本：

Collecting sample(s)
from participants：

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 18 岁 years
最大 Max age 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

This will be a prospective, double-masked, randomized controlled study. Patients will be randomized into Noctura 400 sleep mask 0.03 scotopic trolands group or the standard 2 scotopic trolands group at a ratio of 1:1. The randomization sequence will be generated using a computerized randomization table kept central

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

This will be a prospective, double-masked, randomized controlled study. Patients will be randomized into Noctura 400 sleep mask 0.03 scotopic trolands group or the standard 2 scotopic trolands group at a ratio of 1:1. The randomization sequence will be generated using a computerized randomization table kept central

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

The randomization sequence will be generated using a computerized randomization table kept centrally by a research assistant. All patients and investigators will be masked to the treatment allocation group. Assessors performing the follow-up assessments also will be masked to the patient allocation group.

Blinding：

The randomization sequence will be generated using a computerized randomization table kept centrally by a research assistant. All patients and investigators will be masked to the treatment allocation group. Assessors performing the follow-up assessments also will be masked to the patient allocation group.

是否共享原始数据：

IPD sharing

是Yes

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）：

IPD will not be shared

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

IPD will not be shared

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：

All measurements generated from clinical examinations and imaging in this study will be duplicated into 2 identical sets. One set, in printed hardcopy format, will be kept in the patients’ Hospital Authority medical records. The other set, in both electronic and hardcopy formats, will be filed securely in the Clinical Research Offices of the Department of Ophthalmology & Visual Sciences at the Chinese University of Hong Kong. Electronic version will be kept in password-protected hard-drives and hardcopies will be filed in locked cabinets. Subjects can withdraw their consents from the study at any time. In the event of patient withdrawal, all clinical data of that particular patient will be deleted and eliminated from the files of the Clinical Research Office. The clinical data in the medical records will, however, be retained for clinical management. The issue of confidentiality is the major ethical issue and will be solved by recording the data in a manner that does not allow the participants to be identified (i.e. using a non-recognizable code for each patient). A review of medical records that have been already recorded as part of clinical care, therefore this poses no physical risks.

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

All measurements generated from clinical examinations and imaging in this study will be duplicated into 2 identical sets. One set, in printed hardcopy format, will be kept in the patients’ Hospital Authority medical records. The other set, in both electronic and hardcopy formats, will be filed securely in the Clinical Research Offices of the Department of Ophthalmology & Visual Sciences at the Chinese University of Hong Kong. Electronic version will be kept in password-protected hard-drives and hardcopies will be filed in locked cabinets. Subjects can withdraw their consents from the study at any time. In the event of patient withdrawal, all clinical data of that particular patient will be deleted and eliminated from the files of the Clinical Research Office. The clinical data in the medical records will, however, be retained for clinical management. The issue of confidentiality is the major ethical issue and will be solved by recording the data in a manner that does not allow the participants to be identified (i.e. using a non-recognizable code for each patient). A review of medical records that have been already recorded as part of clinical care, therefore this poses no physical risks.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-06-21 08:13:47