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

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.

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Key information

Conditions

Postpartum Women

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Postpartum depressive symptoms (PND)

Time frame: 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

Time frame: 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

Time frame: 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.

Secondary outcomes

Anxiety

Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Acronym: SLEEP-PD-HK

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: May 20, 2026
Registry last updated: May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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