Sleep Health Care in Pregnancy: A Randomized Controlled Trial

Overview

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.

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Prevention
  • Masking: Triple (Participant, Care Provider, Investigator)
• Study Primary Completion Date: December 31, 2025

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

• 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.

Arms, Groups and Cohorts

• Experimental: Experimental
  • 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.
• No Intervention: Control
  • Women in the control group will receive standard obstetric care.

Clinical Trial Outcome Measures

Primary Measures

• 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • National Taiwan University Hospital
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Shao-Yu Tsai, Principal Investigator, National Taiwan University
• Overall Contact(s)
  • Shao-Yu Tsai, 0905676805, stsai@ntu.edu.tw