Postpartum WomenSLEEP-PD-HKNCT07600593
Sleep Architecture as a Digital Biomarker for Postpartum Depression in Hong Kong Mothers
An observational study of Postpartum Women, run by The University of Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Women
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Postpartum mothers who gave birth within 6 months and reside in Hong Kong
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Postpartum women | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The STAI scale will be reported at 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum WomenStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Dai, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600593
- Sponsor's protocol ID
- 2501262769
- Acronym
- SLEEP-PD-HK
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Architecture as a Digital Biomarker for Postpartum Depression in Hong Kong Mothers
- ClinicalTrials.gov ID
- NCT07600593
- Acronym / sponsor ID
- SLEEP-PD-HK / 2501262769
- Conditions
- Postpartum Women
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postpartum women | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Postpartum mothers who gave birth within 6 months and reside in Hong Kong
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
1 secondary outcome
Anxiety
Time frame: The STAI scale will be reported at 6 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Women, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum depressive symptoms (PND) (time frame: 2 weeks and 6 weeks postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.