Not yet recruiting NCT07600593
Sleep Architecture as a Digital Biomarker for Postpartum Depression in Hong Kong Mothers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Postpartum Women. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Postpartum depressive symptoms (PND) [Time frame: 2 weeks and 6 weeks postpartum]
- Subjective sleep quality [Time frame: The PSQI will be reported once at 6 weeks postpartum.]
- Objective sleep efficiency [Time frame: Objective SE will be measured at 6 weeks postpartum for 14 consecutive days.]
Secondary outcome measures (1)
- Anxiety [Time frame: The STAI scale will be reported at 6 weeks postpartum]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07600593 · 2501262769