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临床试验/NCT06514833
NCT06514833尚未招募不适用

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

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年8月19日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Bayley Scales of Infant and Toddler Development score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

盲法说明

Assessors responsible for conducting the neurodevelopment tests are blinded to the group allocation.

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pregnant women with a PSQI score greater than 5 at enrollment.
  • Not a habitual napper in the past 3 months (defined as napping 5 or more days per week on average for the past month).

排除标准

  • Women with severe respiratory or cardiovascular diseases, liver or kidney dysfunction, or malignant tumors.

结局指标

主要结局

Bayley Scales of Infant and Toddler Development score

时间窗: 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.

次要结局

  • Ages and Stages Questionnaires (ASQ) score(Children at 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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