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

NCT07600593 | Not Yet Recruiting

• 1 other identifier: 2501262769
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postpartum Women

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Anxiety

  The STAI scale will be reported at 6 weeks postpartum

Study Arms (1)

Postpartum women

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only female will be eligible to participate this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share