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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07600593

Acronym

SLEEP-PD-HK

Enrollment

Registered

2026-05-20

Start date

2026-07-01

Completion date

2028-01-31

Last updated

2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Women

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Postpartum depressive symptoms (PND)	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	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	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

Measure	Time frame	Description
Anxiety	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.

Outcome results