跳至主要内容
临床试验/NCT07600593
NCT07600593尚未招募不适用

Sleep Architecture as a Digital Biomarker for Postpartum Depression in Hong Kong Mothers

The University of Hong Kong0 个研究点目标入组 60 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Postpartum depressive symptoms (PND)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Postpartum women

结局指标

主要结局

Postpartum depressive symptoms (PND)

时间窗: 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.

Subjective sleep quality

时间窗: 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.

Objective sleep efficiency

时间窗: 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.

次要结局

  • Anxiety(The STAI scale will be reported at 6 weeks postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ying Dai

Research Assistant Professor

The University of Hong Kong

相似试验

Sleep Architecture as a Digital Biomarker for... | 临床试验