Effects of Napping in Pregnant Women With Sleep Disturbances on Offspring Neurodevelopment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: lifestyle recommendations to nap regularly, No recommendations to nap regularly.
- Who it may be relevant to
- Registry conditions: Sleep. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Regular Napping in Pregnant Women With Sleep Disturbances on Offspring Neurodevelopment
Overview
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.
Interventions
- Behavioral lifestyle recommendations to nap regularly
Participants will receive lifestyle recommendations to nap regularly for 15-30 minutes between 12:00 and 15:00 - Other No recommendations to nap regularly
No lifestyle recommendations to nap regularly
Primary outcome measures
- Bayley Scales of Infant and Toddler Development score [Time frame: Children at 24 months]
Secondary outcome measures (2)
- Ages and Stages Questionnaires (ASQ) score [Time frame: Children at 12 months]
- Ages and Stages Questionnaires (ASQ) score [Time frame: Children at 6 months]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
Women with severe respiratory or cardiovascular diseases, liver or kidney dysfunction, or malignant tumors.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
China · 1 center
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University — Shanghai
Identifiers
NCT: NCT06514833 · XH-24-006