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NCT05694780 Clinical Trial

Sleep Health Care in Pregnancy: A Randomized Controlled Trial

Pregnancy Related Clinical Trial

Official title:
Sleep Health Care in Pregnancy: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05694780
Other study ID # 202209036RINC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date December 31, 2025

Study information
Verified date March 2024
Source National Taiwan University Hospital
Contact Shao-Yu Tsai
Phone 0905676805
Email stsai@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 45 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sleep by actigraphy Actigraphy is an objective sleep measurement method that assesses physical motion through a small device worn on the non-dominant wrist Through study completion, an average of 16 weeks
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