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

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Sleep

Treatments: Behavioral: lifestyle recommendations to nap regularly; Other: No recommendations to nap regularly

Study type: Interventional

Funder types: Other

Identifiers

NCT06514833

XH-24-006

Details and patient eligibility

About

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.

Full description

Participants will be recruited based on the Early Life Plan Project, an ongoing hospital-based prospective birth cohort study. Pregnant women will be recruited at the time of booking for prenatal care. The sleep patterns of pregnant women will be assessed at 12-16 weeks of gestation using the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Women with a PSQI score greater than 5 and who self-report as not being habitual nappers in the last 3 months will be recruited. These women will receive lifestyle recommendations to nap regularly for 15-30 minutes between 12:00 and 15:00. Whether they adopt this lifestyle change or the actual duration of their naps will be entirely up to the participants. An Actiwatch will be given to the participants during early pregnancy (12-14 weeks), mid-pregnancy (22-24 weeks), and late pregnancy (29-32 weeks). Instructions will be included on how to wear the watch, with participants advised to wear it on the non-dominant wrist continuously for 7 days, except when swimming or bathing. In addition to the Actiwatch, participants will complete a sleep questionnaire during early pregnancy (12-14 weeks), mid-pregnancy (26-27 weeks), and late pregnancy (35-37 weeks) to subjectively assess their nighttime sleep and napping over the past month. The neurodevelopment of the participants' offspring will be followed up and assessed using the Bayley Scales of Infant and Toddler Development at 6 months, 12 months, 18 months, and 2 years of age.

Enrollment: 80 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Nap

Experimental group

Description:

The experimental group will receive lifestyle recommendations to nap regularly

Treatment:

Behavioral: lifestyle recommendations to nap regularly

No nap

Other group

Description:

The control group would not receive lifestyle recommendations to nap regularly

Treatment:

Other: No recommendations to nap regularly