Effects of Napping in Pregnant Women With Sleep Disturbances on Offspring Neurodevelopment

NCT06514833 · tracked via the Priya Life Science China tracker

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Phase

Not applicable

Started

2024-08-19

Last updated

2024-07-23

Condition(s) studied

Sleep

Investigational drug(s) / intervention(s)

lifestyle recommendations to nap regularlyNo recommendations to nap regularly

lifestyle recommendations to nap regularly: Participants will receive lifestyle recommendations to nap regularly for 15-30 minutes between 12:00 and 15:00

No recommendations to nap regularly: No lifestyle recommendations to nap regularly

Study summary

To examine the effects of napping in pregnant women with sleep disturbances on offspring neurodevelopment, the researchers will recruit 80 pregnant women with sleep disturbances. These women will receive lifestyle recommendations to nap regularly and will choose whether or not to nap. The participants will wear wrist-worn accelerometers to record their 24-hour sleep patterns for seven consecutive days during the early, middle, and late stages of pregnancy. The neurodevelopment of their offspring will be assessed at 6 months, 12 months, 18 months, and 2 years of age.

Eligibility

Sex

ALL

Min age

20 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Pregnant women with a PSQI score greater than 5 at enrollment. 2. Not a habitual napper in the past 3 months (defined as napping 5 or more days per week on average for the past month). Exclusion Criteria: Women with severe respiratory or cardiovascular diseases, liver or kidney dysfunction, or malignant tumors.

Primary outcome measure(s)

Bayley Scales of Infant and Toddler Development score — Children at 24 months
The Bayley Scales of Infant and Toddler Development (Bayley-III) evaluates five key developmental domains: 1. Cognitive Development. 2. Language Development. 3. Motor Development. 4. Social-Emotional Development. 5. Adaptive Behavior.

Trial sites (1)

Facility	City	Region	Status
Xinhua Hospital Affiliated to Shanghai Jiao Tong University	Shanghai	Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06514833 on ClinicalTrials.gov ↗ ← All trials in China