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Sleep Health Care in Pregnancy: A Randomized Controlled Trial

Sleep Health Care in Pregnancy: A Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05694780
Enrollment
300
Registered
2023-01-23
Start date
2023-01-01
Completion date
2025-12-31
Last updated
2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Related

Brief summary

Sleep disturbances are one of the most frequent complaints brought to the healthcare professionals during routine prenatal care visits.The purpose of this study is to develop and evaluate a Sleep Training and Education Program (STEP) for improving sleep and health in women during pregnancy.

Detailed description

Women in the intervention group will receive standard obstetric care plus the STEP intervention which is a 8-week program based on sleep hygiene education and cognitive-behavioral training.

Interventions

Standard obstetric care plus the sleep intervention which is a 8-week program based on sleep hygiene education and cognitive-behavioral training.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* During the first trimester of pregnancy * Singleton pregnancies

Exclusion criteria

* Women have pregnancy-related complications * Women have diagnosed a psychiatric or sleep disorder

Design outcomes

Primary

MeasureTime frameDescription
Sleep by actigraphyThrough study completion, an average of 16 weeksActigraphy is an objective sleep measurement method that assesses physical motion through a small device worn on the non-dominant wrist

Countries

Taiwan

Contacts

Primary ContactShao-Yu Tsai
stsai@ntu.edu.tw0905676805
Backup ContactJia-Chun Huang
ntuhrec@ntuh.gov.tw(02)3366-7178

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026