NCT06687044

Sleep Improvement Therapy Affects Pregnancy Outcomes in Chinese Singletons and Twins by Improving Sleep Quality

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Jun Wei · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

During pregnancy, the physical and psychological changes of pregnant women, hyperemesis gravidarum, uterine compression, frequent urination, hip or pelvic pain, back pain, leg cramps, gastroesophageal reflux, changes in mental state, and even changes in lifestyle, habits and tastes may affect the sleep of pregnant women. Due to the coexistence of physiological, psychological, social and other complex factors during pregnancy, the incidence of sleep disorders in pregnant women is relatively high, up to 50%, and shows an increasing trend with the increase of gestational week. Not only seriously affect the quality of life of pregnant women, but also may lead to a variety of pregnancy complications, and even lead to adverse pregnancy outcomes. Therefore, early identification, timely diagnosis and treatment of sleep disorders during pregnancy are important measures to improve or even reverse adverse pregnancy outcomes. Although sleep disorders are more common and seriously harmful during pregnancy, people lack of understanding and attention to such diseases, and often regard them as normal clinical manifestations of pregnancy and neglect diagnosis and treatment. Studies have shown that maternal sleep disorders are associated with hypertensive disorders during pregnancy, preterm birth, and gestational diabetes. Current research objects mainly focus on single pregnancy, twin related research is less. The purpose of this study is to explore the perinatal sleep health of pregnant women with twin pregnancies, reduce the complications of pregnant women with twin pregnancies and improve the pregnancy outcomes of mothers and infants by improving sleep quality.

Conditions

• Gestational Diabetes
• Hypertension in Pregnancy
• Preterm Labor
• NICU Infants

Interventions

Type	Name	Description
BEHAVIORAL	Sleep restriction	Go to bed before 23pm
BEHAVIORAL	Stimulation control	Avoid drugs, alcohol, caffeine, and nicotine
BEHAVIORAL	Cognitive therapy	Listen to 30 minutes of soothing music every night for 8 weeks
BEHAVIORAL	Sleep principles discussion	The principles of sleep hygiene are discussed, but without the application of stimulus control or sleep restriction

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2024-11-13
• Last updated: 2024-11-13

Locations

1 site across 1 country: China