Sleep Architecture as a Digital Biomarker for Postpartum Depression in Hong Kong Mothers (SLEEP-PD-HK)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postpartum Women

• Study Type: Observational
• Enrollment (Estimated): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Postpartum mothers who gave birth within 6 months and reside in Hong Kong

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Postpartum women

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postpartum depressive symptoms (PND)	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	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	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	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

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2501262769

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No