Sleep Architecture as a Digital Biomarker for Postpartum Depression in Hong Kong Mothers (SLEEP-PD-HK)
2026年5月13日 更新者：Ying Dai、The University of Hong Kong
The goal of this study is to develop a postpartum depression (PND) Risk index using the UK Biobank dataset, and to validate the risk index in Hong Kong postpartum women.
Participating Hong Kong postpartum women will wear an actigraphy (GENEActive) for 14 consecutive days.
研究概览
地位
尚未招聘
条件
研究类型
观察性的
注册 (估计的)
60
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
- 成人
- 年长者
接受健康志愿者
是的
取样方法
非概率样本
研究人群
Postpartum mothers who gave birth within 6 months and reside in Hong Kong
描述
Inclusion Criteria
- Mothers who are at least 18 years of age and are within 6 months of giving birth.
- Participants must be capable of reading Traditional Chinese, Mandarin, or English, to ensure they can provide informed consent and complete the required study documentation.
Exclusion Criteria
- Individuals with specific conditions that might interfere with the measurement of sleep patterns related to mood will be excluded. This includes mothers diagnosed with sleep apnea or those who use CPAP machines.
- To reduce physiological noise in the data, women working permanent night shifts or those with severe medical complications, such as pre-eclampsia requiring ongoing medication, will also be excluded
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
队列和干预
团体/队列 |
|---|
|
Postpartum women
|
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 |
|---|---|---|
|
Postpartum depressive symptoms (PND)
大体时间：2 weeks and 6 weeks postpartum
|
PND refers to a mood disorder that affects individuals during pregnancy or within 1 year after childbirth.
PND will be measured by the Edinburgh Postnatal Depression Scale (EPDS).
The EPDS score ranges between 0 and 30, with higher score indicating worse PND symptoms.
|
2 weeks and 6 weeks postpartum
|
|
Subjective sleep quality
大体时间：The PSQI will be reported once at 6 weeks postpartum.
|
Subjective sleep quality will be measured both subjectively by the Pittsburgh Sleep Quality Index (PSQI).
The PSQI score ranges between 0 and 21, with a higher score indicating worse subjective sleep quality.
|
The PSQI will be reported once at 6 weeks postpartum.
|
|
Objective sleep efficiency
大体时间：Objective SE will be measured at 6 weeks postpartum for 14 consecutive days.
|
Objective sleep efficiency (SE) will be measured by the accelerometer (GENEActiv).
The unit for SE is percentage, and the mathematical bounds are 0% (minimum) to 100% (maximum).
However, in human populations, healthy adults typically score between 85% and 90%.
A higher percentage indicates a higher SE.
|
Objective SE will be measured at 6 weeks postpartum for 14 consecutive days.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Anxiety
大体时间：The STAI scale will be reported at 6 weeks postpartum
|
Anxiety will be measured by the State-Trait Anxiety Inventory (STAI).
The STAI score ranges between 20 and 80, with higher scores indicate more severe anxiety symptoms.
|
The STAI scale will be reported at 6 weeks postpartum
|
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。
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 (估计的)
2026年7月1日
初级完成 (估计的)
2027年6月30日
研究完成 (估计的)
2028年1月31日
研究注册日期
首次提交
2026年5月6日
首先提交符合 QC 标准的
2026年5月13日
首次发布 (实际的)
2026年5月20日
研究记录更新
最后更新发布 (实际的)
2026年5月20日
上次提交的符合 QC 标准的更新
2026年5月13日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- 2501262769
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
To comply with the IRB for this study, the data will not be shared with other researchers.
All collected data will be stored securely for 5 years following study completion, in accordance with institutional research data management policies.
Access to the Qualtrics survey responses will be strictly limited to the principal investigator, co-investigators and research assistants.
Data will be stored in password-protected files on encrypted servers, and all identifying information will be removed during data analysis and reporting.
After the 5-year retention period, all data will be permanently deleted by overriding each file.
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.