Improving sleep health in pregnant women
Sleep Health Care in Pregnancy: A Randomized Controlled Trial
This study is testing a new program to help pregnant women sleep better and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei, Taipei) |
| Trial ID | NCT05694780 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and evaluate a Sleep Training and Education Program (STEP) designed to improve sleep quality and overall health in pregnant women. Participants in the intervention group will receive standard obstetric care along with an 8-week program that focuses on sleep hygiene education and cognitive-behavioral training. The study seeks to address the common issue of sleep disturbances during pregnancy, which can impact both maternal and fetal health. By comparing outcomes between the intervention and control groups, the effectiveness of the STEP program will be assessed.
Who should consider this trial
Good fit: Ideal candidates for this study are women in their first trimester of singleton pregnancies.
Not a fit: Patients with pregnancy-related complications or diagnosed psychiatric or sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance sleep quality and health outcomes for pregnant women.
How similar studies have performed: While there is limited data on similar interventions specifically for pregnant women, cognitive-behavioral approaches to sleep improvement have shown promise in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Taipei, Taipei
- National Taiwan University Hospital — Taipei, Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Shao-Yu Tsai — National Taiwan University
- Study coordinator: Shao-Yu Tsai
- Email: stsai@ntu.edu.tw
- Phone: 0905676805
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.