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

N/ANot Yet RecruitingNCT07600593

The University of Hong Kong60 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Postpartum Women

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Objective SE will be measured at 6 weeks postpartum for 14 consecutive days.

Secondary Outcomes

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.

Time frame: The STAI scale will be reported at 6 weeks postpartum

Data from ClinicalTrials.gov

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