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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Preterm Labor; Gestational Diabetes; Hypertension in Pregnancy; NICU Infants
• Intervention / Treatment: Behavioral: Sleep restriction; Behavioral: Stimulation control; Behavioral: Cognitive therapy; Behavioral: Sleep principles discussion

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital Of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: (1) Pregnant women aged 18-45 years. (2) Diagnosed with single or twin pregnancy within 12 weeks of pregnancy, report sleep quality problems, agree to participate in the study and sign the informed consent -

Exclusion Criteria:Have a prior serious underlying medical condition (e.g., diabetes, heart disease), mental illness, or other serious sleep disorder

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep improvement Therapy group(CBT-I)	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
Placebo Comparator: Control group (TAU)	Behavioral: Sleep principles discussion; The principles of sleep hygiene are discussed, but without the application of stimulus control or sleep restriction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypertension in pregnancy	Pregnancy induced hypertension (PIH) is hypertension that occurs after 20 weeks of gestation in women with previously normal blood pressure.	From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)
Gestational diabetes mellitus	Gestational diabetes mellitus (GDM) is defined as glucose intolerance of variable degree with onset or first recognition during pregnancy	From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)
Preterm labor	Preterm labor is parturition that occurs when birth occurs between 28 weeks of gestation and 37 weeks	From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)
NICU infants	Neonatal NICU occupancy rate	From the data of randomization until the date of the end of this pregnancy (up to 50 weeks)

Collaborators and Investigators

• Sponsor: Jun Wei

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 8, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Estimated): November 13, 2024

Study Record Updates

• Last Update Posted (Estimated): November 13, 2024
• Last Update Submitted That Met QC Criteria: November 11, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Obstetric Labor Complications; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Hypertension; Diabetes, Gestational; Hypertension, Pregnancy-Induced; Obstetric Labor, Premature
• Other Study ID Numbers: Sleep improvement therapy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No