Clinical trial NCT06514833: Effects of Napping in Pregnant Women With Sleep Disturbances on Offspring Neurodevelopment
Official title: Effects of Regular Napping in Pregnant Women With Sleep Disturbances on Offspring Neurodevelopment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sleep
Keywords: Sleep disturbance
Neurodevelopment
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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 outcomes:
measure: Bayley Scales of Infant and Toddler Development score
timeFrame: Children at 24 months
Secondary outcomes:
measure: Ages and Stages Questionnaires (ASQ) score
timeFrame: Children at 12 months
measure: Ages and Stages Questionnaires (ASQ) score
timeFrame: Children at 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Xinhua Hospital Affiliated to Shanghai Jiao Tong University
name: Yun Huang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: