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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorThe University of Hong Kong

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 1 trial group
Group A: Postpartum women

Trial outcomes

Primary outcomes

1

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
2

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.
3

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

1

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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