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NCT Number: NCT05694780

Sleep Health Care in Pregnancy: A Randomized Controlled Trial

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.

Recruiting

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Key information

Conditions

Pregnancy Related

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 10051, Taiwan

Location status: Recruiting

Location contact

Shao-Yu Tsai

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep intervention

Behavioral

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

Primary outcomes

  1. Sleep by actigraphy

    Time frame: Through study completion, an average of 16 weeks

    Actigraphy is an objective sleep measurement method that assesses physical motion through a small device worn on the non-dominant wrist

Study contacts

Contact information is provided by the study sponsor or research team.

Jia-Chun Huang

CONTACT

[email protected]

(02)3366-7178

Shao-Yu Tsai

CONTACT

[email protected]

0905676805

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2023
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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