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

May 13, 2026 updated by: Ying Dai, The University of Hong Kong

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Postpartum women

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postpartum depressive symptoms (PND)
Time Frame: 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.
2 weeks and 6 weeks postpartum
Subjective sleep quality
Time Frame: 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.
The PSQI will be reported once at 6 weeks postpartum.
Objective sleep efficiency
Time Frame: 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.
Objective SE will be measured at 6 weeks postpartum for 14 consecutive days.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: 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.
The STAI scale will be reported at 6 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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